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U.S. Department of Health and Human Services

Class 3 Device Recall Irix Gamma Camera

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  Class 3 Device Recall Irix Gamma Camera see related information
Date Initiated by Firm November 21, 2007
Date Posted September 19, 2008
Recall Status1 Terminated 3 on February 25, 2012
Recall Number Z-1511-2008
Recall Event ID 45894
510(K)Number K964712  
Product Classification Scintillation (gamma) camera - Product Code KPS
Product Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
Code Information Model Numbers: 210857 and 210881.  4535 679 46991, or N210857 Irix System, 3/8" Crystal 4535 665 13551, or N210881 Irix System 3/4" Crystals 4535 679 46981, or N211038 Irix System 3/8 Precision 4535 665 13571, or N211040 Irix System 3/4 Precision (Note: Due to a part number scheme change at the firm, either number is representative of the identified system)
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact Melinda Novatny
440-483-4255
Manufacturer Reason
for Recall		 Resistor Failure: The Rotate Motion Shunt Resistor may overheat and results in the appearance of smoke, a burning smell, and an electronic stop condition, which will disable the gamma camera rotate motion and all other motions.
FDA Determined
Cause 2		 Component design/selection
Action Consignees were sent an Urgent Field Safety Notice on 1/30/08. The letter instructs users who experience a failure to remove the system from service and contact the recalling firm for immediate correction. The recalling firm will schedule appointments with users to replace the affected part beginning in March 2008. For additional information, contact 1-800-722-9377.
Quantity in Commerce Unknown at this time sinc the recall was expanded.
Distribution Worldwide Distribution --- USA including states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, Puerto Rico and countries of Argentinia, Austrailia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Netherlands, Norway, Philipines, Poland, Singapore, South Africa, Spain, Switzerland, 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 = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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