The Recall Desk
SevereFDA (Devices)·Z-1411-2018·Announced 2018-04-25

Philips Brilliance Big Bore CT Systems Recalled for Emergency Stop Defect

Philips is recalling 119 Brilliance Big Bore CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect that could cause injury to patients during load or unload activities, meeting the criteria for a Severe rating.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 119 Brilliance Big Bore (Radiology) Computed Tomography X-Ray systems, Model no. 728244. The recall is due to a defect where closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

The affected units were distributed worldwide, including in the United States, Canada, Mexico, and numerous international locations. The recall covers specific serial numbers listed in the official FDA notice.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. Patients and consumers should not use the affected equipment until the issue is resolved by the manufacturer.

The recalled product

Product
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and pla
Affected units
119

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →