FDA (Devices) recall action 93643
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.
While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
The agency’s own wording, quoted from the enforcement report.
Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.
Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.
Philips BrightView XCT gamma cameras may pose an extremity entrapment hazard during certain scanning operations. A gap can form between the patient support and detector, risking fractures, lacerations, and crush injuries.