Innova
Innova IGS 620 002 UDI
7manufacturers in China registered for this device type
2catalogue numbers in this listing
10510(k) clearances naming this product code
34recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Beijing (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 3 |
Record
| Listed by | GE Medical Systems, LLC, United States |
|---|---|
| FDA product code | IZI |
| Device type | System, X-Ray, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1600 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K122457 |
| Record published | 2016-09-24 |
| Record revised | 2025-08-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UPG X100 001 | Withdrawn | |
| IGS 620 002 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterimed | Sterimed, Inc. | 114 |
| Med-Syringe | Argon Medical Devices, Inc. | 16 |
| Control Syringe | Argon Medical Devices, Inc. | 14 |
| Novadaq and Pinpoint | Novadaq Technologies, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 12 |
| Namic | Navilyst Medical, Inc. | 9 |
| Namic | Medline Industries, Inc. | 8 |
| iMRX System | Imris Imaging, Inc. | 6 |
| System, X-Ray, Angiographic | B. Braun Medical Inc. | 4 |
| System, X-Ray, Angiographic | Intuitive Surgical, Inc. | 3 |
| Leica FL800 | Leica Microsystems (Schweiz) AG | 3 |
| Infrared 800 with Flow® 800 Option | Carl Zeiss Meditec Inc | 2 |
Showing 12 of 51. All products under System, X-Ray, Angiographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974367 | 1998-02-13 |
| K973270 | 1997-11-25 |
| K973368 | 1997-10-17 |
| K960575 | 1996-05-07 |
| K945375 | 1995-01-30 |
| K943355 | 1994-11-07 |
| K942120 | 1994-07-18 |
| K941946 | 1994-05-20 |
| K926258 | 1993-03-15 |
| K905653 | 1991-05-15 |
Recalls Naming This Product
20 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, 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 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
9 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 |
|---|---|---|---|---|---|
| 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. | 1 device | |
| 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 | |
| 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 |
| 2011-12-20 | Class II | Radiation Control for Health and Safety Act | It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems. | 199 installed in the US | 2013-09-18 |
| 2011-12-20 | Class II | Radiation Control for Health and Safety Act | It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems. | 199 installed in the US | 2013-09-18 |
| 2011-12-20 | Class II | Radiation Control for Health and Safety Act | It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems. | 199 installed in the US | 2013-09-18 |
| 2011-05-04 | Not classified | Radiation Control for Health and Safety Act | It was discovered that when the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and enabled on the Diamentor M4-KDK which is not certified as required by FDA regulation (Subpar | 19 | 2012-03-29 |
| 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 | 60 | 2015-12-03 |
| 2008-01-14 | Not classified | Process control | Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system | 252 | 2011-12-17 |
| 2004-03-24 | Not classified | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. | 2006-07-24 | |
| 2004-03-24 | Not classified | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. | 2006-07-24 | |
| 2004-03-24 | Not classified | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. | 2006-07-24 | |
| 2004-03-24 | Not classified | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. | 2006-07-24 | |
| 2004-03-24 | Not classified | Other | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. | 2006-07-24 |
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.