FDA-Device2016-09-14Class II
BrightView XCT Upgrade Model 882454
Philips Medical Systems (Cleveland) Inc
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.
Sold states
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.
Affected count
3 units
Manufactured in
595 Miner Rd, Cleveland, OH, United States
Products
BrightView XCT Upgrade Model 882454
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2737-2016Don't want to check this manually?
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