Philips North America: Incisive CT Plus-Computed Tomography X-Ray System Model: 728149

Hazard

Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

Details from the source

Reason for recall: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down Distribution: Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federati Quantity: 6 units OUS Lot/code info: UDI-DI: (01)00884838103474(21) Serial Numbers: 530408 530437 530474 530320 530332 530430

UPC codes

00884838103474

Source

Official record: FDA (Device enforcement) ↗

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