DigitalDiagnost C90, Model No. 712034 and 712035
This recall is currently active, issued June 30, 2023. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- May 19, 2023
- Posted
- June 30, 2023
- Recall Number
- Z-2042-2023
- Quantity
- 58
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
There is a software login in issue that may prevent the user from logging in.
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
Lot / Code Info
1) UDI-DI (01)00884838090699, Model 712034, serial numbers: 10000074, 10000083, 10000163, 10000188, 10001057, 10001071, 10001072, 10001079, 10001089, 10001106, 10001133, 10001136, 10001137, 10001142, 10001146, 10001169, 10001180, 10001181, 10001186, 10001203, 10001211, 10001229, 10001234, 10001276, 19861179, 19861365, 21860026, 21860084, 21861001, 21861233, 21861386, 21861415, 21861416, 21861493, 21861528, 22860017, 22860114, 22860115, 22860448, 22860454, SN19000006, SN20861092, SN20861107, SN20861108, SN20861115, SN20861125, SN20861126, and SN20861128 2) UDI-DI (01)00884838090705, Model 712035, serial numbers: 10000034, 10000098, 10001051, 10001113, 10001130, 21860040, 22860052, SN20862021, SN20862022, and SN20862024
Root Cause
Software change control
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.