—#181316

Product

ProxiDiagnost N90, UDI 706100

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173433
Affected lot / code info: Serial Numbers: SN18000022 SN19000005 10000047 SN18000019 20000047 20000054 10000011 10000021 10000010 10000026 10000015 SN18000011 10000000 10000009 10000004 10000005 SN18000015 SN19000008 SN19000009 10000019 10000036 20000052 SN18000007 10000033 SN18000014 10000001 10000039 20000051 SN18000004 SN18000016 SN18000018 SN19000004 SN19000011 SN19000015 SN19000018 10000008 20000045 20000053 10000006 10000022 10000048 10000017 10000012 20000039 20000044 SN19000014 10000040 10000043 SN19000017 20000026 SN19000012 SN18000006 SN18000012 SN18000017 10000014 SN18000013 SN19000013 10000030 SN18000225 SN18000024 10000049 SN19000007 SN19000010 10000041 10000046 SN18000009 SN19000001 SN19000016 10000023 10000024 10000025 10000050 20000043 10000028 SN18000002 10000020 SN18000003 SN18000023 SN19000002 SN19000003 SN19000006 10000013 10000016 10000018 SN18000020 SN18000005 20000048

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Domestic distribution nationwide. Foreign distribution to Chile and Germany.

Timeline

Recall initiated: 2020-04-23
Terminated: 2023-03-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181316. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.