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.
What this means for you
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
- Hazard
- unstable-connection
- incomplete-scan
- sensor
Distribution
Distribution scope not specified by the agency.
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