FDA (Devices) recall action 73010
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 discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
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 677 BrightView gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.
Philips is recalling 427 BrightView XCT gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.
Philips Medical Systems is recalling 117 BrightView X gamma cameras worldwide due to potential gantry motion halts and collimator contact with the patient pallet.