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Philips Medical Systems (Cleveland) Inc recalls BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Recalled September 14, 2016 · FDA recall Z-2735-2016 · 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
117 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 X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →