Philips CT Systems Recalled Due to Potential Oil Accumulator Bolt Failure
Philips is recalling 112 Computed Tomography X-Ray Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.
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 is classified as FDA Class II. The hazard involves a mechanical component failure (bolt failure) that could lead to equipment damage or potential injury, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 112 units of Computed Tomography X-Ray Systems, including the Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, and GEMINI Dual models. These devices are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
The recall is being conducted because a bolt that attaches the oil accumulator within the gantry may fail. This failure could result in the oil accumulator detaching from the tube housing assembly within the gantry. The affected units were distributed worldwide, including in the United States and various international markets.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address this defect. No specific consumer action is required for the general public, as these are professional medical devices.
The recalled product
- Product
- Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images o
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 112
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 #: 728130
- Serial #: 8128
- 8158 & 8369. System Code #: 728256
- Serial #: 3695
- 3703
- 371 &
- 3719. System Code #: 728246
- Serial #: 3463
- 3508
- 3519
- 3548
- 3552
- 3591
- 3592
- 3593
- 3603
- 3637
- 3648
- 3654
- 3659
Distribution
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
- ModeratePhilips Forte Gamma Camera System Recalled for Detector Fall Hazard
FDA (Devices) · 2019-11-13
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28