Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
FDA device recall Z-1510-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 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, T
- Date initiated
- 2007-11-21
- Date posted
- 2008-09-19
- Date terminated
- 2012-02-25
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRISM XPVT SYSTEM (210823) (K964712) | Philips Medical Systems (Cleveland), Inc. | 1997-02-21 |