DigitalDiagnost C90, Model No. 712034 and 712035
FDA Recall Z-2042-2023 · Posted 2023-06-30
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Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeMQB
Date Initiated2023-05-19
Product Quantity58
Reason for Recall
There is a software login in issue that may prevent the user from logging in.
Firm 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 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
Distribution Pattern
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
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.
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