Philips North America: Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148

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: 53 units OUS Lot/code info: UDI-DI: (01)00884838103467 (21) Serial Numbers: 530456 530338 530360 530489 530370 530363 530389 530369 530481 530350 530464 530500 530436 530301 530501 530372 530466 530368 530476 530358 530294 530421 530435 530480 530458 530342 530432 530419 530460 530502 530349 530475 530482 530431 530335 530378 530494 530492 530470 530345 530461 530374 530384 530388 530357 530404 530329 530373 530409 530462 530420 530452 530307

UPC codes

00884838103467

Source

Official record: FDA (Device enforcement) ↗

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