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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare DuraDiagnost

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  Class 2 Device Recall Philips Healthcare DuraDiagnost see related information
Date Initiated by Firm November 10, 2015
Date Posted June 03, 2016
Recall Status1 Terminated 3 on May 03, 2017
Recall Number Z-1696-2016
Recall Event ID 74083
510(K)Number K141381  
Product Classification System, x-ray, stationary - Product Code KPR
Product Philips Healthcare DuraDiagnost stationary X-ray system
Code Information software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5
Recalling Firm/
Manufacturer		 Philips Healthcare
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		 The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call 1-800- 722-9377.
Quantity in Commerce 5
Distribution USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
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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