Philips and Neusoft Recall NeuViz 16 CT Scanners Due to Detached Oil Accumulator
Philips and Neusoft are recalling 15 NeuViz 16 CT scanners because a screw failure caused the oil accumulator to detach from the X-ray tube.
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, and the source text does not report any illnesses or injuries, which aligns with the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips and Neusoft Medical Systems Co., Ltd. are recalling 15 units of the NeuViz 16 Multi-Slice CT Scanner System. The recall is due to a mechanical defect where one of the four screws securing the oil-accumulator to the X-Ray Tube pulled out, causing the oil-accumulator to detach.
The affected devices are distributed nationwide in North Carolina, Ohio, and Texas. The specific serial numbers for the recalled units are N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N16E1 00023, N16E1 10016, N16E1 10023, N16E1 10026, N16E1 10027, N16E1 10040, and N16E1 10053.
Healthcare facilities should contact the recalling firm to arrange for inspection and repair of the affected devices. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS
- Manufacturer
- Philips And Neusoft Medical Systems Co., Ltd.
- Hazard
- Affected units
- 15
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 (15)
- Serial No.: N16E0 90002
- N16E0 90003
- N16E0 90004
- N16E0 90007
- N16E0 90008
- N16E0 90010
- N16E1 00015
- N16E1 00017
- N16E1 00023
- N16E1 10016
- N16E1 10023
- N16E1 10026
- N16E1 10027
- N16E1 10040
- and N16E1 10053.
Distribution
Related recalls
Same manufacturer · Philips And Neusoft Medical Systems Co., Ltd.
See all →- HighPhilips NeuViz 16 CT Scanner Recall for Patient Data Error
FDA (Devices) · 2016-05-04
- HighPhilips NeuViz Dual CT Scanner Recalled for Pinch Hazard
FDA (Devices) · 2013-05-01
- HighPhilips NeuViz 16 CT Scanner Recalled Due to Pinch Hazard
FDA (Devices) · 2013-05-01
- HighPhilips and Neusoft Recall CT Scanners Due to Detaching Patient Table
FDA (Devices) · 2012-12-12
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