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U.S. Department of Health and Human Services

Class 2 Device Recall DigitalDiagnost C90

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 Class 2 Device Recall DigitalDiagnost C90see related information
Date Initiated by FirmMay 19, 2023
Date PostedJune 30, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2042-2023
Recall Event ID 92462
510(K)NumberK202564 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductDigitalDiagnost C90, Model No. 712034 and 712035
Code Information 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
FEI Number 3016618143
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactCustomer Care Solutions Center
800-722-9377
Manufacturer Reason
for Recall		There is a software login in issue that may prevent the user from logging in.
FDA Determined
Cause 2		Software change control
ActionConsignees 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 Commerce58
DistributionDistribution 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MQB
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