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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare DuraDiagnost Xray system

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  Class 2 Device Recall Philips Healthcare DuraDiagnost Xray system see related information
Date Initiated by Firm September 17, 2015
Date Posted September 01, 2016
Recall Status1 Terminated 3 on August 31, 2017
Recall Number Z-2682-2016
Recall Event ID 74685
510(K)Number K141381  
Product Classification System, x-ray, stationary - Product Code KPR
Product Philips DuraDiagnost stationary X-ray system
Code Information SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		 Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips plans to bring the products into compliance with the Federal standard at no cost to customers by implementing a field correction. 1. You will contact customers and initiate the actions to correct the failure to comply issues. 2. You will attach the warning label to maintain an audible volume, and issue a supplement to the user manual that instructs the user how to adjust the volume for the local noise environment and include a warning that the user shall maintain an audible volume. 3. You will attach the identification label to the affected Height-Adjustable Tabletop. 4. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. If you need any further information or support concerning this, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.
Quantity in Commerce 15
Distribution US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPR and Original Applicant = PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
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