Philips Brilliance iCT SP CT Systems Recalled for Emergency Stop Defect
Philips is recalling 19 Brilliance iCT SP 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 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 poses a significant risk of injury to patients during loading and unloading, meeting the criteria for a Severe rating.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 19 units of the Brilliance iCT SP Computed Tomography X-Ray system (Model no. 728311). 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 units were distributed worldwide, including in the United States, Canada, Mexico, and numerous other countries. Specific serial numbers for the affected units are listed in the recall documentation.
Healthcare facilities should contact Philips Medical Systems to arrange for the necessary corrective actions to address the emergency stop functionality and ensure patient safety during patient positioning.
The recalled product
- Product
- Brilliance iCT SP - Model no. 728311 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
- 19
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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