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U.S. Department of Health and Human Services

Class 2 Device Recall ProxiDiagnost N90

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 Class 2 Device Recall ProxiDiagnost N90see related information
Date Initiated by FirmDecember 08, 2020
Date PostedJanuary 28, 2021
Recall Status1 Terminated 3 on June 21, 2024
Recall NumberZ-0727-2021
Recall Event ID 87039
510(K)NumberK173433 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Code Information Pending
Recalling Firm/
Manufacturer		 PHILIPS HOME HEALTHCARE SOLUTION
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall		After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
Quantity in Commerce91
DistributionNationwide
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
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