Incisive CT systems recalled over an unstable connection inside the floating sensor
Philips Healthcare (Suzhou) is recalling 35 Incisive CT systems over the potential for an incomplete scan due to an unstable connection inside the floating sensor.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequence is an incomplete scan, with no patient harm or reported injury.
Plain-English summary
The Philips Incisive CT is being recalled by Philips Healthcare (Suzhou) Co., Ltd.
The reason given in the enforcement record is the potential for an incomplete scan due to an unstable connection inside the floating sensor.
The record lists 35 units, with no product codes given. Distribution was in the United States and US territories. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is an incomplete scan, and no injuries are reported. Facilities should follow Philips' instructions.
The recalled product
- Product
- Philips Incisive CT
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
- Category
- Medical Device — CT scanner
- Affected units
- 35
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Philips Healthcare (Suzhou) Co., Ltd.
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighPhilips Incisive CT Scanner Software Issues May Cause Misdiagnosis
FDA (Devices) · 2024-01-17
- HighPhilips CT Systems Recalled for Potential Couch Movement Failure
FDA (Devices) · 2021-03-24
Same hazard · unstable connection
See all →- HighAvanta administration tube sets may not engage the flow control valve
FDA (Devices) · 2026-06-10
Similar recalls
- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighPhilips CT Systems Recalled for Potential Couch Movement Failure
FDA (Devices) · 2021-03-24
- HighCT scanners recalled over six software faults affecting movement and dose
FDA (Devices) · 2025-11-05
- ModerateIncisive CT systems recalled because tube heat exchanger screws may not be tightened
FDA (Devices) · 2025-12-10
- HighCT Scanner Component Fracture Risk in Incisive System
FDA (Devices) · 2024-05-29
- HighPhilips Incisive CT Scanner Software Issues May Cause Misdiagnosis
FDA (Devices) · 2024-01-17