Z-2042-2023Class II

DigitalDiagnost C90, Model No. 712034 and 712035

Name: Z-2042-2023 DigitalDiagnost C90, Model No. 712034 and 712035
Creator: Philips North America Llc
Published: 2023-05-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-05-19 / Open, Classified / root cause: software

FDA source

Philips North America Llc began a recall of DigitalDiagnost C90, Model No. 712034 and 712035 on 2023-05-19. FDA classified it as Class II and gives the reason as "There is a software login in issue that may prevent the user from logging in". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2042-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-19
Posted: 2023-06-30
Recalling firm: Philips North America LLC
Product: DigitalDiagnost C90, Model No. 712034 and 712035
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: There is a software login in issue that may prevent the user from logging in.
Root cause tag: software
FDA 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 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.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2042-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2042-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29

Product code MQB

K202564Class IIDigitalDiagnost C90Philips Medical Systems Dmc GmbH / cleared 2020-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)