Recall Z-2256-2020 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips North America, LLC
ProxiDiagnost N90, UDI 706100
| Date | Apr 23, 2020 |
| Status | Terminated |
| Reason | The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke. |
| Root cause | Process control |
| Action | On April 23, 2020, the firm distributed Urgent Field Safety Notice letters to affected customers. Customers were informed of the product issue. According to the notice, the customer can use the system according to the IfU (Instruction for Use). The user should pay attention to whether it smells of smoke in the room. If this is the case, immediately shut down the system according to IFU or (if present) use emergency off switch in room, remove patient, stop using the system for further examinations and contact customer service. Philips plans to perform an On-Site check of the SPDU thermo con |
| Quantity | 91 |
| Distribution | Domestic distribution nationwide. Foreign distribution to Chile and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173433 | ProxiDiagnost N90 Philips Medical Systems Dmc GmbH, Feb 5, 2018 |