Recall Z-2042-2023 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips North America Llc
DigitalDiagnost C90, Model No. 712034 and 712035
| Date | Jun 30, 2023 (initiated May 19, 2023) |
| Status | Open, Classified |
| Reason | There is a software login in issue that may prevent the user from logging in. |
| Root cause | Software change control |
| Action | Consignees in the United States were notified via Urgent Medical Device Correction Letter that was distributed on May 26, 2023. US consignees were initially notified via email. Follow-up notifications via FedEx will follow. Philips Market Organizations are responsible for distributing letters outside of the US in accordance with local requirements. A Philips Field Service Engineer will visit impacted customer sites to perform a software upgrade to prevent the issue from recurring. Philips has requested customers perform the following: a) To prevent the system from becoming inoperable, do not |
| Quantity | 58 |
| Distribution | Distribution in US: AZ, GA, IN, IA, MN, NE, NH, OH, TX OUS distribution to Australia, Chile, China, Malta, Namibia, New Zealand, Oman, Panama, Qatar, Suriname, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202564 | DigitalDiagnost C90 Philips Medical Systems Dmc GmbH, Sep 30, 2020 |