Philips Brilliance CT 64 Systems Recalled for Unexpected Couch Descent
Philips is recalling 153 Brilliance CT 64 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 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 153 units of the Brilliance CT 64 computed tomography X-ray system. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The recall was initiated after the firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so. This malfunction presents a risk of injury to patients or operators.
The affected units were distributed in China. The specific units are identified by System Code # 728231 and specific serial numbers listed in the official recall notice. Users of these systems should contact the manufacturer for instructions on how to address the defect.
The recalled product
- Product
- Brilliance CT 64. 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
- 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 (20)
- System Code #
- 728231
- Serial #
- 9568
- 9758
- 10097
- 10143
- 10267
- 10269
- 10275
- 10427
- 10436
- 10521
- 10545
- 10579
- 10622
- 90097
- 90218
- 95203
- 95319
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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