Recalls / —
—#200971
Product
DigitalDiagnost C90, Model No. 712034 and 712035
- FDA product code
- MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K202564
- Affected 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
Why it was recalled
There is a software login in issue that may prevent the user from logging in.
Root cause (FDA determination)
Software change control
Action the firm took
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.
Recalling firm
- Firm
- Philips North America Llc
- Address
- 222 Jacobs St, Cambridge, Massachusetts 02141-2289
Distribution
- 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
Timeline
- Recall initiated
- 2023-05-19
- Posted by FDA
- 2023-06-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #200971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.