Allia
Allia IGS 7 OR UDI
5manufacturers in China registered for this device type
2catalogue numbers in this listing
11510(k) clearances naming this product code
25recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| 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 |
Record
| Listed by | GE Medical Systems, LLC, United States |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K181403 |
| Record published | 2021-03-31 |
| Record revised | 2024-03-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 70 to 103 KiloPascal; Storage environment temperature 10 to 40 °C; Storage environment humidity 10 to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IGS 7 OR 001 | In distribution | |
| IGS 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Trinias | Shimadzu Corp. | 54 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Intelli-C Accessory | Nrt – Nordisk Røntgen Teknik A/S | 13 |
| Pulse | Nuvasive, Inc. | 12 |
| O-ARM® | Medtronic Navigation, Inc. | 11 |
| Genoray | Genoray Co., Ltd. | 10 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061163 | 2006-06-07 |
| K060259 | 2006-02-22 |
| K050489 | 2005-03-11 |
| K042053 | 2004-08-26 |
| K033244 | 2003-10-16 |
| K031637 | 2003-08-22 |
| K024200 | 2003-01-16 |
| K023178 | 2002-11-26 |
| K022322 | 2002-10-08 |
| K993037 | 2000-02-14 |
| K936180 | 1994-03-16 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label or 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 | UDI-DI | 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 | 2 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. | 22 devices |
Recalls
24 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 |
|---|---|---|---|---|---|
| 2026-04-20 | Class II | Device Design | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, mainte | 3 units | |
| 2026-04-20 | Class II | Device Design | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, mainte | 5 units | |
| 2026-04-20 | Class II | Device Design | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, mainte | 121 units | |
| 2026-04-20 | Class II | Device Design | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, mainte | 9 units | |
| 2026-04-20 | Class II | Device Design | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, mainte | 35 units | |
| 2025-07-02 | Class II | Radiation Control for Health and Safety Act | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead | ||
| 2025-07-02 | Class II | Radiation Control for Health and Safety Act | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead | ||
| 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 |
| 2016-04-15 | Class II | Device Design | Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure. | 25 | 2016-11-22 |
| 2016-04-15 | Class II | Device Design | Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure. | 54 | 2016-11-22 |
| 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 |
| 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 | 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 |
| 2015-05-29 | 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 |
| 2014-12-10 | Class II | Software design | Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products. | 24 ( 7 US, 17 OUS) | 2015-06-01 |
| 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. | 1 – OUS | 2015-01-21 |
| 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. | 6 (1 US, 5 OUS) | 2015-01-21 |
| 2013-12-12 | Class II | Device Design | GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potenti | 816 (722 US, 94 OUS). | 2014-09-11 |
| 2013-12-11 | Class II | Software design | GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional im | 257(159 US, 98 OUS) | 2014-07-29 |
| 2013-08-16 | Class II | Process control | GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular | 2184 (1063 US. 1121 OUS) | 2014-05-30 |
| 2013-06-19 | Class II | Software design | GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting | 4 (2 US, 2 OUS) | 2013-10-25 |
| 2011-12-20 | Class II | Nonconforming Material/Component | While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries hav | 713 | 2014-03-13 |
| 2011-10-21 | Class II | Labeling design | As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff m | 48 | 2014-02-04 |
| 2011-05-16 | Class II | Software design | GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems. | 48 | 2014-03-13 |
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.