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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Diagnost Rel 3

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  Class 2 Device Recall Digital Diagnost Rel 3 see related information
Date Initiated by Firm November 01, 2011
Date Posted November 30, 2011
Recall Status1 Terminated 3 on January 17, 2017
Recall Number Z-0313-2012
Recall Event ID 60323
510(K)Number K982795  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product Philips Digital Diagnost Rel 3, a radiographic system, digital

Intended use: Radiographic system, digital
Code Information S/N:  SN11000009 SN11000012 SN11000014 SN11000015 SN11000016 SN11000017 SN11000025 SN11000029 SN11000013 SN11000020 SN11000022 SN11000005 SN11000008 SN11000010 SN11000003 SN11000019 SN11000034 SN11000004 SN11000018 SN11000023 SN11000024 SN11000006 SN11000007 SN11000011 SN11000026 SN11000027 SN11000028 SN11000002                        
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		 Missing a small, metal protective cover on the bottom side of the control handle for the ceiling suspension. exposes printed circuit
FDA Determined
Cause 2		 Process control
Action The firm, Philips Healthcare, sent a "URGENT - Field Safety Notice" letter dated October 25, 2011, to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed: Do not place your hand in the open slot below the Control Handle and ensure that no patient places his/her hands the opening; review the following information with all members of their staff who need to be aware of the contents of this communication, and retain a copy with the equipment instruction for use. Philips has issued a Field Change order instructing Service Engineers to check affected systems and install the cover where it is missing free of charge. If you need any further information or support concerning this issue call 978-659-4519.
Quantity in Commerce 28 (7 US; 2 Canada; 19 OUS)
Distribution Worldwide distribution: USA (nationwide) including states of: NC, SC, TX, and WV; and countries of: Australia, Austria,Canada, Germany, Italy, Netherlands, Sweden, and Switzerland.
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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