DigitalDiagnost C90, Model No. 712034 and 712035
FDA device recall Z-2042-2023 · posted 2023-06-30 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- There is a software login in issue that may prevent the user from logging in.
- Action taken
- 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 reboot or log out of your system until Philips has implemented the software correction; b) Circulate this notice to all users of the device so that they are aware of the issue; and c) Complete and return the response form to Philips promptly and no later than 30 days from receipt.
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- MQB
- Quantity affected
- 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
- Date initiated
- 2023-05-19
- Date posted
- 2023-06-30
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DigitalDiagnost C90 (K202564) | Philips Medical Systems Dmc GmbH | 2020-09-30 |