Philips Brilliance iCT CT Systems Recalled for Emergency Stop Defect
Philips is recalling 295 Brilliance iCT CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.
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 risk-of-harm product (medical device) where injury has not yet been reported, which corresponds to a High severity score under the rubric.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 295 Brilliance iCT Computed Tomography X-Ray systems (Model no. 728306). 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 across the United States and numerous international locations. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the issue. The recall number is Z-1408-2018.
The recalled product
- Product
- Brilliance iCT - Model no. 728306 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 planes. These…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 295
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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