Innova
Innova IGS 630 002 UDI
9manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
33recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | GE Medical Systems, LLC, United States |
|---|---|
| FDA product code | JAA |
| Device type | System, X-Ray, Fluoroscopic, Image-Intensified |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K122457 |
| Record published | 2016-08-01 |
| Record revised | 2025-08-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IGS 530 002 | Withdrawn | |
| IGS 5 001 | Withdrawn | |
| IGS 630 002 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Preferred Medical Products, LLC | Preferred Medical Products, LLC | 324 |
| Unbranded | Advance Medical Designs, Inc. | 301 |
| N23 CCD System | Nical SPA | 57 |
| N33 CCD System | Nical SPA | 36 |
| Trinias | Shimadzu Corp. | 31 |
| Custom Cover | Advance Medical Designs, Inc. | 15 |
| Pulse | Nuvasive, Inc. | 15 |
| Sonialvision G4 | Shimadzu Corp. | 13 |
| LessRay | Nuvasive, Inc. | 13 |
| Micro Kover | Advance Medical Designs, Inc. | 11 |
| Stephanix | Stephanix | 10 |
| Snap Kover | Advance Medical Designs, Inc. | 9 |
Showing 12 of 169. All products under System, X-Ray, Fluoroscopic, Image-Intensified
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061028 | 2006-06-07 |
| K011624 | 2001-06-08 |
Recalls Naming This Product
26 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems SCS | 510(k) number | 2024-03-18 | Class II | Process control | GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fa | 21 units | |
| GE Medical Systems SCS | 510(k) number | 2024-03-18 | Class II | Process control | GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fa | 3 units | |
| GE Medical Systems SCS | 510(k) number | 2024-03-18 | Class II | Process control | GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fa | 1 unit | |
| GE Medical Systems SCS | 510(k) number | 2024-03-18 | Class II | Process control | GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fa | 1 unit | |
| GE Medical Systems, LLC | 510(k) number | 2021-04-19 | Class II | Component change control | The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen. | 139 devices | 2023-08-31 |
| GE Medical Systems, LLC | 510(k) number | 2019-03-15 | Class II | Device Design | There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously. | 49 devices | |
| GE Medical Systems, LLC | 510(k) number | 2019-03-15 | Class II | Device Design | There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously. | 22 devices | |
| GE Medical Systems SCS | 510(k) number | 2018-03-29 | Class II | Process control | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. | 102 devices total | 2021-06-15 |
| GE Medical Systems SCS | 510(k) number | 2018-03-29 | Class II | Process control | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use. | 102 devices total | 2021-06-15 |
| GE Medical Systems, LLC | 510(k) number | 2015-12-18 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. | 2,111 (1078 US; 1033 OUS) | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2015-11-13 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems. | 108 | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2015-11-13 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems. | 45 | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 3 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 4 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 13 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 1 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 6 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 2 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 10 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 17 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 6 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 3 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 8 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2015-05-29 | Class II | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). | 7 | 2015-10-28 |
| GE Medical Systems, LLC | 510(k) number | 2014-09-04 | Class II | Device Design | Loss of imaging – affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism. | 10 (4 US, 6 OUS). | 2015-01-21 |
| GE Medical Systems, LLC | 510(k) number | 2013-11-15 | Class II | Software design | GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the us | 28 (12 US, 16 OUS). | 2014-03-28 |
Recalls
16 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-12-10 | Class II | Other | GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient or | 113 units | 2022-11-18 |
| 2019-03-29 | Class II | Device Design | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. | 825 (38 US and 787 OUS) in total | 2021-04-15 |
| 2019-03-29 | Class II | Device Design | There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging. | 825 (38 US and 787 OUS) in total | 2021-04-15 |
| 2016-11-21 | Class II | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors – Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. | Total for all products 1,598 (USA 824, OUS 774) | 2017-09-26 |
| 2016-11-21 | Class II | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors – Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. | Total for all products 1,598 (USA 824, OUS 774) | 2017-09-26 |
| 2016-11-21 | Class II | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors – Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. | Total for all products 1,598 (USA 824, OUS 774) | 2017-09-26 |
| 2016-11-21 | Class II | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors – Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. | Total for all products 1,598 (USA 824, OUS 774) | 2017-09-26 |
| 2016-11-21 | Class II | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors – Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. | Total for all products 1,598 (USA 824, OUS 774) | 2017-09-26 |
| 2016-11-21 | Class II | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors – Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. | Total for all products 1,598 (USA 824, OUS 774) | 2017-09-26 |
| 2015-06-12 | Class II | Nonconforming Material/Component | A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F syst | 788 (701 US; 87 OUS) | 2017-08-03 |
| 2015-06-12 | Class II | Nonconforming Material/Component | The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (2 | 4,053 (3,804 US; 249 OUS) | 2015-12-21 |
| 2015-06-12 | Class II | Nonconforming Material/Component | A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F syst | 788 (701 US; 87 OUS) | 2017-08-03 |
| 2014-09-05 | Class II | Employee error | GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging system | 204 (199 US, 5 OUS). | 2015-02-20 |
| 2013-11-08 | Class II | Employee error | Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of t | 5651 | 2014-11-03 |
| 2013-08-30 | Class II | Employee error | GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This is | 810 (783 US, 27 OUS) | 2014-05-22 |
| 2013-05-02 | Class II | Device Design | GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension y | 445 (421 US, 24 OUS) | 2013-11-26 |
| 2010-06-10 | Not classified | Radiation Control for Health and Safety Act | Use of high force when moving the image carriage/IDD into forward/park position can cause changes to the mechanical alignment of the collimator blades and allow the blades to open wider than specified, consequently allowing radiation outsid | 440 US | 2014-09-15 |
| 2009-04-16 | Not classified | Device Design | Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monit | 15 AND 46 UNLOCATED | 2015-12-03 |
| 2008-05-01 | Not classified | Radiation Control for Health and Safety Act | The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard. | 54 (24 US / 30 OUS) | 2011-12-17 |
| 2008-05-01 | Not classified | Radiation Control for Health and Safety Act | The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard. | 54 (24 US / 30 OUS) | 2011-12-17 |
| 2008-05-01 | Not classified | Radiation Control for Health and Safety Act | The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard. | 54 (24 US / 30 OUS) | 2011-12-17 |
| 2008-05-01 | Not classified | Radiation Control for Health and Safety Act | The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard. | 61 (32 US / 29 OUS) | 2012-01-07 |
| 2008-01-02 | Not classified | Nonconforming Material/Component | GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube whe | 2863 total (2744 US / 119 OUS) | 2011-12-10 |
| 2007-12-18 | Not classified | Device Design | GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick | 6 | 2012-08-09 |
| 2007-12-18 | Not classified | Device Design | GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick | 66 | 2012-08-09 |
| 2007-12-18 | Not classified | Device Design | GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick | 193 | 2012-08-09 |
| 2007-10-04 | Not classified | Radiation Control for Health and Safety Act | It was reported that when the GE Precision 500D foot pedal is repeatedly activated, a defect in the fluoro-timer will cause the dose measurement to report a higher value than was actually received by the patient. Patient will receive a lo | 106 | 2012-08-09 |
| 2007-08-13 | Not classified | Radiation Control for Health and Safety Act | Necessary certification labels are missing from the x-ray contol. | 437 | 2010-10-07 |
| 2007-08-13 | Not classified | Radiation Control for Health and Safety Act | Necessary certification labels are missing from the x-ray contol. | 448 | 2010-10-07 |
| 2007-08-01 | Not classified | Software design | Inaccurate cassette size display reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger film cassette is inserted into the table Bucky (replacing a smaller cassette) after a protocol is selected on the console, the | 101 | 2008-09-10 |
| 2006-11-01 | Not classified | Other | Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv) | 83 | 2008-02-24 |
| 2006-05-15 | Not classified | Other | Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the | 1,289 | 2007-05-25 |
| 2004-12-30 | Not classified | Other | Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur. | 921 | 2006-02-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability.
Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.