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U.S. Department of Health and Human Services

Class 2 Device Recall CombiDiagnost R90

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  Class 2 Device Recall CombiDiagnost R90 see related information
Date Initiated by Firm July 22, 2020
Create Date August 28, 2021
Recall Status1 Open3, Classified
Recall Number Z-2357-2021
Recall Event ID 88393
510(K)Number K203087  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product CombiDiagnost R90
Software Version R1.0 and R1.1
Code Information Model 706100
Recalling Firm/
Manufacturer		 Philips Medical Systems Gmbh, DMC
Development And Manufacturing Ctr.
Rontgenstr. 24-26
Hamburg Germany
For Additional Information Contact
40-50782110
Manufacturer Reason
for Recall		 Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips sent customers an Electronic Product Radiation Correction letter dated July 14, 2021. The letter identified the affected product, problem and actions to be taken. Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. For questions contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO70900051.
Quantity in Commerce 322 systems; 66 in US
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JAA and Original Applicant = Philips Medical Systems DMC GmbH
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