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U.S. Department of Health and Human Services

Class 2 Device Recall MultiDiagnost 4

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  Class 2 Device Recall MultiDiagnost 4 see related information
Date Initiated by Firm January 10, 2003
Date Posted February 27, 2003
Recall Status1 Terminated 3 on April 11, 2005
Recall Number Z-0586-03
Recall Event ID 25406
510(K)Number K961374  
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product MultiDiagnost 4 - x-ray system, multi functional/universal system for general use.
Code Information Serial numbers include (but are not limited to): 4584520996, 4594911196, 4595090397, 4595290697, 4594871196, 4594841196, 4595130197, 4615641197, 4595240797, 459500197, 4615511097, 4615581097, 4584570996, 4615320897, 459516497, 4595070197, 4584320996, 4584721096, 4615661197, 4594980197  Part numbers: 9896 000 58511, 9896 000 58512, 9896 000 58521, 9896 000 58522  
Recalling Firm/
Manufacturer		 Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact Sarah Baxter
425-487-7765
Manufacturer Reason
for Recall		 INTERNAL SHORT CIRCUIT - MAY ALLOW FOR STAND AND TABLE TO MOVE SPONTANEOUSLY IN UPWARD OR DOWNWARD MOVEMENT
FDA Determined
Cause 2		 Other
Action The firm issued a letter dated January 10, 2003 to their customers advising of the problem and that a respresentative would be contacting customers to arrange a time to visit to install new interface board. This is being conducted under FCO 70800007
Quantity in Commerce 22 units
Distribution The firm distributed to 22 hospitals/medical centers located in CA, FL, IA, IL, IN, KY, MN, MO, NC, ND, NY, OH, SC, TN, TX, VA, and WV.
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 = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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