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.
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 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.
See all 11 products in this recall →Related recalls
Same manufacturer · Philips Medical Systems (Cleveland) Inc
See all →- HighRadiation planning software recalled over image errors in three patient orientations
FDA (Devices) · 2025-09-24
- HighPinnacle 3 radiation planning software may miscalculate stopping power ratio
FDA (Devices) · 2025-08-13
- HighPinnacle3 Radiation Therapy Planning System dose-calculation software error
FDA (Devices) · 2022-09-21
- SeverePhilips Forte Gamma Camera System Recalled for Detector Fall Hazard
FDA (Devices) · 2019-11-13
- SeverePhilips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
FDA (Devices) · 2019-11-13
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModeratePhilips Brilliance 16 CT Systems Recalled for Software Defect
FDA (Devices) · 2016-08-17
- HighPhilips Brilliance 16 Slice CT System Recalled for Emergency Stop Defect
FDA (Devices) · 2018-04-25
- ModeratePhilips Brilliance 16 Air CT Systems Recalled for Collimator Defect
FDA (Devices) · 2019-04-24
- ModeratePhilips Brilliance CT 16 Power Systems Recalled for Software Defect
FDA (Devices) · 2016-08-17
- LowPhilips Brilliance CT 16 System Recalled for Software Logout Failure
FDA (Devices) · 2012-09-26
- ModeratePhilips Brilliance 16 CT Scanner Recalled for Image Reconstruction Defect
FDA (Devices) · 2016-08-31