EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
FDA Recall Z-2523-2020 · Posted 2020-07-10
Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeJAA
Date Initiated2020-06-02
Date Terminated2021-02-09
Product Quantity52
Reason for Recall
Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.
Firm Action
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
Distribution Pattern
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.
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.