Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
FDA Recall Z-1510-2008 · Posted 2008-09-19
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2007-11-21
Date Terminated2012-02-25
Product QuantityUnknow at this time since the recall was expanded.
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.