Philips Brilliance CT 16 Air Recalled for Unexpected Couch Descent
Philips is recalling 153 Brilliance CT 16 Air systems because the patient couch may unexpectedly descend to its lowest point during an exam.
What this means for you
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 the hazard (unexpected couch descent) could cause injury, but no injuries have been reported yet, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 153 units of the Brilliance CT 16 Air computed tomography X-ray system. The recall was initiated after the firm was informed that the patient couch unexpectedly descended to the lowest point without being commanded to do so while raising the couch to perform an exam.
The affected systems were distributed in China. The recall includes specific system code and serial numbers listed in the official FDA notice. No injuries or illnesses have been reported in the source text.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. Consumers should not use the affected equipment until the issue is resolved.
The recalled product
- Product
- Brilliance CT 16 Air. 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 #
- 728246
- Serial #
- 3376
- 3393
- 3444
- 3466
- 3650
- 4055
- 5234
- 5239
- 5311
- 5366
- 5387
- 5388
- 5403
- 5408
- 5417
- 5418
- 5420
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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