Recall Z-0461-2026 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems DMC GmbH
ProxiDiagnost N90; Model Number: 706110;
| Date | Nov 7, 2025 (initiated Oct 1, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 th |
| Quantity | 41 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, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) Philips Medical Systems Dmc GmbH, Jan 11, 2024 |