Radiography 7300 C; Model Number: 712037;
FDA device recall Z-0466-2026 · posted 2025-11-07 · Open, Classified
Recall details
- Recalling firm
- Philips Medical Systems DMC GmbH
- Reason for recall
- 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/physical exertion required for manual movement) due to potential manufacturing issues.
- Action taken
- On October 1, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 30, 2025, were sent to customers. The letters described the problem, product and actions to be taken. Actions to be taken: It is safe to continue to use the system(s) in accordance with the intended use. It is recommended that customers use the motorized movement option until the technical solution has been implemented. The system may experience motor drive errors if the force for movement exceeds 110N, which restricts the motorized movement. If the motorized movement does not function, customers should contact their local service representative. B. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. C. Please retain this Urgent Medical Device Correction letter with your system(s) until the solution is installed; ensure the notice is in a place likely to be seen/viewed. 5. Actions planned by Philips to correct the problem. Philips will provide the technical solution details when finalized. This notice has been reported to the appropriate Regulatory Agencies. If you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM 8PM EST, Monday-Friday).
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KPR
- Quantity affected
- 284 units
- Distribution
- Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France
- Date initiated
- 2025-10-01
- Date posted
- 2025-11-07
- Location
- Hamburg, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Radiography 7300 C (K233662) | Philips Medical Systems Dmc GmbH | 2024-06-13 |