FDA (Devices) recall action 83201
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.
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
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 117 BrightView X devices because a handcontroller issue may cause spontaneous or continued motion.
Philips Medical Systems is recalling 427 BrightView XCT devices because a handcontroller issue may cause uncommanded motions or continued motion after buttons are released.
Philips Medical Systems is recalling 696 BrightView SPECT units because the handcontroller may move spontaneously or continue moving after buttons are released.