Philips Brilliance 16 Slice CT System Recalled for Emergency Stop Defect
Philips is recalling two Brilliance 16 Slice CT systems because the emergency stop may fail to 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 where the emergency stop fails to disable the motor, allowing the couch to move during patient handling. No injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling two units of the Brilliance 16 Slice (Air) Computed Tomography X-Ray system, Model no. 728246. The recall involves serial numbers 50231 and 30019. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.
The recall is due to a defect where closing the Emergency Stop may fail to 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 staff.
The affected units were distributed worldwide, including the United States, Canada, Mexico, and numerous other countries. Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue.
The recalled product
- Product
- Brilliance 16 Slice (Air) - Model no. 728246, 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.…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 2
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: 50231 30019
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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