Discovery
Discovery IGS 7 OR UDI
3manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (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 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | GE Medical Systems, LLC, United States |
|---|---|
| FDA product code | OXO |
| Device type | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K181403 |
| Record published | 2018-02-10 |
| Record revised | 2025-08-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2022-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IGS 7 OR 001 | Withdrawn | |
| IGS 7 001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O-ARM® | Medtronic Navigation, Inc. | 16 |
| Cios Select | Siemens Shanghai, Medical Equipment Ltd. | 3 |
| Smart-C | Turner Imaging Systems, Inc. | 3 |
| Zenition | Philips Medical Systems Nederland B.V. | 2 |
| Broach Set SPX1 | Ecential Robotics | 2 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | Ecotron Co., Ltd. | 2 |
| Flourocsan InSight | Hologic, Inc. | 2 |
| Genoray | Genoray Co., Ltd. | 2 |
| 3D Imaging Set SPX1 | Ecential Robotics | 2 |
| OEC | Ge Hualun Medical Systems Co., Ltd. | 2 |
| Cios Alpha | Siemens Healthcare Limited | 1 |
| System, X-RAY, Fluoroscopic, Image-Intensified | Gemss Medical Systems Co., Ltd. | 1 |
Showing 12 of 40. All products under Image-Intensified Fluoroscopic X-Ray System, Mobile
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K980322 | 1998-04-24 |
| K933447 | 1993-08-23 |
Recalls Naming This Product
6 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. | 22 devices |
Recalls
6 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 |
|---|---|---|---|---|---|
| 2025-03-21 | Class II | Process control | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | Total for both products: 3472 (2,919 US; 553 OUS) | |
| 2025-03-21 | Class II | Process control | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. | Total for both products: 3472 (2,919 US; 553 OUS) | |
| 2012-09-20 | Class II | Radiation Control for Health and Safety Act | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by | 364 total units installed in US | 2013-12-05 |
| 2012-09-20 | Class II | Radiation Control for Health and Safety Act | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by | 364 total units installed in US | 2013-12-05 |
| 2012-09-20 | Class II | Radiation Control for Health and Safety Act | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by | 364 total units installed in US | 2013-12-05 |
| 2012-09-20 | Class II | Radiation Control for Health and Safety Act | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by | 364 total units installed in US | 2013-12-05 |
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.