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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 01, 2026
Date PostedJune 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2354-2026
Recall Event ID 98940
510(K)NumberK202564 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductDigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Code Information Model Number: 712035. UDI: (01)00884838090705(21)24861049. Lot Code: 24861049.
FEI Number 3016618143
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information ContactCustomer Care Solution Center
800-722-9377
Manufacturer Reason
for Recall		System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
FDA Determined
Cause 2		Device Design
ActionPhilips Medical notified the single consignee on about 05/01/2026 via mailed letter. The consignee was notified of the issue, potential risk, and instructed to Stop using the Wall Stand VS2 immediately to ensure patient and user safety while Philips provides the Seismic Bucky Unit 2 (BU2) Skyplate kit, do not attempt to inspect, adjust, or install any mechanical components of the Wall Stand yourself, circulate this Urgent Medical Device Correction letter to all users of this device so that they are aware of the issue and associated impact, and complete and return the provided response form. A Philips representative will contact the consignee to schedule a time for a Field Service Engineer (FSE) to visit the site to install a hardware correction.
Quantity in Commerce1 unit
DistributionUS distribution to California.
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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