—#66437

Product

Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K964712
Affected lot / code info: 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)

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

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.

Timeline

Recall initiated: 2007-11-21
Posted by FDA: 2008-09-19
Terminated: 2012-02-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66437. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.