ProxiDiagnost N90, UDI 706100
FDA Recall Z-2256-2020 · Posted None
Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeJAA
Date Initiated2020-04-23
Date Terminated2023-03-30
Product Quantity91
Reason for Recall
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.
Firm 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 contact at affected systems, which will eliminate these issues.
Should you need to communicate with Philips with regard to this program, please reference Field Change Order 70600101.
If you need any further information or support concerning this issue, please contact your local Philips representative.
Root Cause
Process control
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Chile and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.