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Discovery
GE Hualun Medical Systems Co., Ltd · Model XR656 HD Upgrade · UDI-DI 00840682136709
10
510(k) clearances
1,218
Adverse events (5 deaths)
168
Recalls
82
Facilities
Description
XR656HD UDI Label
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-09 | FUJIFILM Healthcare Americas Corporation | It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be suppl |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph |
| 2025-09-15 | FUJIFILM Healthcare Americas Corporation | It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the |
| 2025-03-10 | Philips North America Llc | Potential for collimator to fall as a result of incorrect installation. |
| 2025-03-10 | Philips North America Llc | Potential for collimator to fall as a result of incorrect installation. |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure tech |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure tech |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure tech |
| 2025-01-28 | GE Medical Systems, LLC | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure tech |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.