Recall Z-2523-2020 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips North America, LLC
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
| Date | Jul 10, 2020 (initiated Jun 2, 2020) |
| Status | Terminated |
| Reason | Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction. |
| Root cause | Process control |
| 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) us |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031535 | PHILIPS EASYDIAGNOST ELEVA Philips Medical Systems North America Co., Jun 17, 2003 |