Philips Brilliance 64 CT System Recalled for Emergency Stop Defect
Philips Medical Systems is recalling six Brilliance 64 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, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling six units of the Brilliance 64 Computed Tomography X-Ray system (Model no. 728231). The recall involves serial numbers 9541, 10207, 9890, 9633, 10561, and 10655. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.
The recall was initiated because closing the Emergency Stop may disable the horizontal motor. This malfunction allows the couch top to move during patient load or unload activities, posing a risk of injury to patients or operators. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including the United States, Canada, Mexico, and numerous international locations. Healthcare facilities and users of these specific serial numbers should contact Philips Medical Systems for further instructions on corrective actions.
The recalled product
- Product
- Brilliance 64 - Model no. 728231, 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
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial no: 9541 10207 9890 9633 10561 10655
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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