Class 3 Device Recall Rotate Motion Shunt Resistor Kit

• Date Initiated by Firm: November 21, 2007
• Date Posted: September 19, 2008
• Recall Status: Terminated on February 25, 2012
• Recall Number: Z-1512-8
• Recall Event ID: 45894
• 510(K)Number: K964712
• Product Classification: Scintillation (gamma) camera - Product Code KPS
• Product: Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
• Code Information: Lot Numbers: 4535 664 01241 and N753360
• 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: 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 since 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