Z-1511-2008

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

Name: Z-1511-2008 Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2007-11-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-11-21 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143 on 2007-11-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1511-2008
Status: Terminated
Initiated: 2007-11-21
Posted: 2008-09-19
Terminated: 2012-02-25
Recalling firm: Philips North America LLC
Product: Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: design
FDA 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 in commerce: Unknown at this time sinc 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, 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.
Product codes and lots: 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)

Product code KPS

K964712Class IIPrism Xpvt System (210823)Philips Medical Systems (Cleveland), Inc. / cleared 1997-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)