Philips North America Llc DigitalDiagnost C90, Model No. 712034 and 712035 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DigitalDiagnost C90, Model No. 712034 and 712035
Brand
Philips North America Llc
Lot Codes / Batch Numbers
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
Products Sold
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
Philips North America Llc is recalling DigitalDiagnost C90, Model No. 712034 and 712035 due to There is a software login in issue that may prevent the user from logging in.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a software login in issue that may prevent the user from logging in.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, GA, IN, IA, MN, NE, NH, OH, TX
Page updated: Jan 10, 2026