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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare DuraDiagnost X Ray

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  Class 2 Device Recall Philips Healthcare DuraDiagnost X Ray see related information
Date Initiated by Firm February 09, 2015
Date Posted May 19, 2015
Recall Status1 Terminated 3 on June 14, 2016
Recall Number Z-1555-2015
Recall Event ID 70916
510(K)Number K141381  
Product Classification System, x-ray, stationary - Product Code KPR
Product Philips Healthcare DuraDiagnost X- Ray
Code Information DuraDiagnost Stationary X-ray System.
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Dusty Leppert, CHP
978-659-7892
Manufacturer Reason
for Recall		 The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Philips Healthcare Planned action: 1. Philips healthcare will contact customers and initiate a software update to correct the software deficiency causing the problem. 2. Philips engineers will install the software. 3. Philips engineers will perform testing to ensure the software update was effective. 4. Corrections are to be made free of charge 5. Corrective actions should be completed by August 15, 2015 For further questions call (978) 659-7892
Quantity in Commerce 3 DuraDiagnost
Distribution Worldwide Distribution - Nationwide Distribution and the countries of Australia, Austria, Argentina, Canada, China, Chile, Colombia Czech Republic, Great Britain, Germany, Egypt, Finland, France, India, Ireland, Japan, Malaysia, Macedonia, Mexico, Netherlands, New Zealand, Nepal, Peru, Poland, Russia, Saudi Arabia Singapore, Switzerland, Sweden, Spain, United Arab Emirates and United Kingdom.
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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