FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
- Recall number
- Z-1511-2008
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
- Status
- Terminated
- Initiated
- 2007-11-21
- Posted
- 2008-09-19
- Terminated
- 2012-02-25
- 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
- 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.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K964712"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28