Recall Z-1510-2008 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
| Date | Sep 19, 2008 (initiated Nov 21, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | Unknow 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, Belgiu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964712 | PRISM XPVT SYSTEM (210823) Philips Medical Systems (Cleveland), Inc., Feb 21, 1997 |