Philips Brilliance CT Big Bore Oncology Recalled for Unexpected Couch Descent
Philips Medical Systems is recalling 153 Brilliance CT Big Bore Oncology systems because the patient couch may unexpectedly descend during an exam.
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 153 units of the Brilliance CT Big Bore Oncology computed tomography X-ray system. The recall was initiated after the firm was informed that the patient couch unexpectedly descended to its lowest point without being commanded to do so while raising the couch to perform an exam.
The affected systems were distributed in China. The specific system code is 728243 and the serial number is 7039. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. Patients and operators should be aware of the potential for the couch to move unexpectedly during procedures.
The recalled product
- Product
- Brilliance CT Big Bore Oncology. 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
- Hazard
- Affected units
- 153
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 (4)
- System Code #
- 728243
- Serial #
- 7039
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 11 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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