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.
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 3/5 (High).
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…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- 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.
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Similar recalls
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