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U.S. Department of Health and Human Services

Class 2 Device Recall Philips DigitalDiagnost Systems

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  Class 2 Device Recall Philips DigitalDiagnost Systems see related information
Date Initiated by Firm August 14, 2012
Date Posted September 14, 2012
Recall Status1 Terminated 3 on January 17, 2017
Recall Number Z-2384-2012
Recall Event ID 62884
510(K)Number K982795  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Philips DigitalDiagnost Systems with M Cabinet
Model: 712025

Stationary radiographic system, digital-Universal RAD Applications
Code Information Lot or Serial Numbers With affected M-cabinet CXA;  Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003
Recalling Firm/
Manufacturer		 Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact Beth St. Germain
978-687-1501
Manufacturer Reason
for Recall		 Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.
FDA Determined
Cause 2		 Device Design
Action Philips Healthcare Imaging issued an Urgent - Field Safety Notice dated August 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The unit will be exchanged with a new unit that complies with the IEC requirements. Please reference Field Change Order (FCO) 71200081 when contacting I your local Philips representative. 1-800-722-9377. Customer were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter and to maintain a copy of the letter with the equipment instruction for Use. For further assistance, customers should contact their local Phillips representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 978-687-1501.
Quantity in Commerce 4 systems
Distribution Worldwide Distribution - USA including OH and WA and the country of Canada
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 = MQB and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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