Recalls / —

—#181817

Product

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

FDA product code

JAA — System, X-Ray, Fluoroscopic, Image-Intensified

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K031535

Affected lot / code info

Serial Numbers  SN16000004  SN17000018  SN17000020  SN17000025  SN17000026  SN18000002  SN18000004  SN18000005 SN16000002 SN16000006 SN16000011 SN16000013 SN16000017 SN16000022 SN16000025 SN16000028 SN16000029 SN16000030 SN16000031 SN16000036 SN16000037 SN16000039 SN16000041 SN16000042 SN16000043 SN16000044 SN16000045 SN16000048 SN16000054 SN16000056 SN17000001 SN17000006 SN17000008 SN17000015 SN17000017 SN17000019 SN17000021 SN17000023 SN17000027 SN17000028 SN17000029 SN17000031 SN17000032 SN17000033 SN17000034 SN17000035 SN17000036 SN17000037 SN17000038 SN18000001  SN18000003  SN18000009

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Philips North America, LLC

Address

3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated

2020-06-02

Posted by FDA

2020-07-10

Terminated

2021-02-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #181817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.