Philips North America Llc: Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143

Hazard

Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity

Details from the source

Reason for recall: Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity Distribution: Worldwide - US Nationwide distribution. Quantity: 18 units Lot/code info: UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers- Applied to FCO72800819: 500046, 500064, 500074, 500102, 500110, 500111, 500145, 500168, 500178, 500211 500216, 500217, 500222, 500225, 500230, 500240, 500242. Serial Number-Applied to FCO72800820 : 500615

UPC codes

00884838085015

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.