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Philips Medical Systems (Cleveland) Inc recalls BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Recalled September 14, 2016 · FDA recall Z-2736-2016 · Philips Medical Systems (Cleveland)
Hazard
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script. · FDA Class II
Units
424 units
Sold at
Worldwide distribution. US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
Description
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
Product
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →