The Recall Desk
HighFDA (Devices)·Z-1410-2018·Announced 2018-04-25

Philips CT Scanner Recall Due to Emergency Stop Defect

Philips is recalling 106 Brilliance Big Bore CT scanners because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading or unloading.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect that poses a risk of physical injury to patients during loading or unloading. No injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 106 units of the Brilliance Big Bore (Oncology) Computed Tomography X-Ray system, Model no. 728243. The recall is due to a defect where closing the Emergency Stop may disable the horizontal motor. This malfunction allows the couch top to move during patient load or unload activities.

The affected devices are distributed worldwide, including in the United States, Canada, Mexico, and numerous other countries. The specific serial numbers for the 106 affected units are listed in the official recall documentation.

Healthcare facilities should contact Philips Medical Systems for instructions on how to address this issue. Patients and staff should be aware of the potential for unexpected couch movement during patient positioning if the Emergency Stop is engaged.

The recalled product

Product
Brilliance Big Bore (Oncology) - Model no. 728243, 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 plan
Affected units
106

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 →