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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- 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.
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