FDA (Devices) recall action 74894
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips Medical Systems is recalling 424 BrightView XCT gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.
Philips Medical Systems is recalling 117 BrightView X gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.
Philips is recalling three BrightView XCT Upgrade units due to a software defect that may cause the detector to contact patients during specific scans.