EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

FDA device recall Z-2523-2020 · posted 2020-07-10 · Terminated

Recall details

Recalling firm

Philips North America, LLC

Reason for recall

Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

Action taken

The firm distributed Urgent Field Safety Notice letters to affected customers on 6/2/2020. Customers were informed that the thermos switches may be incorrectly installed which results in a malfunction. If the transformer overheats due to a failure and the thermos switch is not activated, the device may begin to generate smoke. Customers were advised by the firm that they 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 70600103. If you need any further information or support concerning this issue, please contact your local Philips representative.

Root cause

Process control

Status

Terminated

Product code

JAA

Quantity affected

52

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CT, FL, GA, HI, IL, LA, MA, MD, MI, MS, MT, NC, NY, TN, TX and the country of Panama.

Date initiated

2020-06-02

Date posted

2020-07-10

Date terminated

2021-02-09

Location

Andover, MA

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