—#66436

Product

Axis 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: 210714, 210880 and 211037 Part Numbers: 4535 665 13461, or N210714 Axis System, 3/8" Crystals 4535 665 16601, or N210880 Axis System 3/4" Crystals 4535 665 12921, or N211037 Axis System 3/8 Precision 4535 665 13501, or N211039 Axis System 3/4 Precision 4535 679 46301, or N211280 Axis System 3/8 Precision 4535 671 67421, or N211282 Axis 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 #66436. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.