Philips Brilliance iCT CT Systems Recalled for Unexpected Couch Descent
Philips Medical Systems is recalling 153 Brilliance iCT computed tomography 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 where the patient couch may unexpectedly descend, posing a potential injury risk, but the source text does not report any actual injuries or illnesses.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 153 units of the Brilliance iCT computed tomography (CT) 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 to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so. This unexpected movement poses a risk of injury to patients or operators.
The affected units were distributed in China. The specific system code is 728306, and the affected serial numbers are 100067, 100137, 100179, 100226, 100233, 100293, 100294, and 100342. Users of these systems should contact Philips Medical Systems for further instructions on how to address the defect.
The recalled product
- Product
- Brilliance iCT. 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 (10)
- System Code #
- 728306
- Serial #
- 100067
- 100137
- 100179
- 100226
- 100233
- 100293
- 100294 & 100342.
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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