Optima
Designated Medical Device Assembly, Optima XR240amx HD Upgrade
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1), 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 |
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| Suzhou Powersite Electric Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | GE Medical Systems, L.L.C. |
|---|---|
| FDA product code | IZL |
| Device type | System, X-Ray, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1720 |
| 510(k) | K142383 |
| Record published | 2016-08-01 |
| Record revised | 2026-02-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XR220amx | In distribution | |
| XR240amx | In distribution | |
| XR240amx HD Upgrade | In distribution | |
| XR200amx | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 27 |
| AcuityPDR | RadmediX, LLC | 24 |
| Sedecal | Sedecal., Sa. | 20 |
| Drgem | Drgem Corporation | 10 |
| DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 7 |
| MinXray | Minxray, Inc. | 6 |
| System, X-Ray, Mobile | Ecotron Co., Ltd. | 6 |
| MobileDaRt Evolution | Shimadzu Corp. | 5 |
| Nomad MD™ handheld X-ray system | Aribex, Inc. | 5 |
| Portable X-ray Unit | Ajex Meditech., Ltd. | 5 |
| Diagnostic X-ray Unit | Poskom Co., Ltd. | 4 |
| FDR Aqro | Fujifilm Corporation | 4 |
Showing 12 of 75. All products under System, X-Ray, Mobile
Recalls Naming This Product
10 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 | 2026-06-05 | Class II | Process control | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the i | 4 units | |
| GE Medical Systems, LLC | 510(k) number | 2026-06-05 | Class II | Process control | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the i | 38 units | |
| GE Medical Systems, LLC | 510(k) number | 2026-06-05 | Class II | Process control | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the i | 24 units | |
| GE Medical Systems, LLC | 510(k) number | 2024-11-25 | Class II | Component design/selection | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the inte | 53 units | |
| GE Medical Systems, LLC | 510(k) number | 2024-11-25 | Class II | Component design/selection | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the inte | 281 units | |
| GE Medical Systems, LLC | 510(k) number | 2024-11-25 | Class II | Component design/selection | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the inte | 120 units | |
| GE Medical Systems, LLC | 510(k) number | 2015-12-23 | Class II | Device Design | Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a | 2389 | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2015-12-23 | Class II | Device Design | Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a | 895 | 2016-09-07 |
| GE Medical Systems, LLC | 510(k) number | 2014-12-19 | Class II | Radiation Control for Health and Safety Act | An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec. | 6 units in US | 2015-04-29 |
| GE Medical Systems, LLC | 510(k) number | 2014-12-19 | Class II | Radiation Control for Health and Safety Act | An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec. | 6 units in US | 2015-04-29 |
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.