Philips CT Systems Recalled for Potential Couch Movement Failure
Philips is recalling 109 CT systems because a defect in the Incisive CT couch actuators could cause the couch to fail to self-lock and move downward unexpectedly.
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 medical device with a mechanical defect that poses a risk of harm (unexpected movement) to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Healthcare (Suzhou) Co., Ltd. is recalling 109 Philips CT systems due to a defect in the actuators used in the Incisive CT couch. The issue was internally detected by the manufacturer and could result in the couch failing to self-lock, causing it to move slowly and unexpectedly downward to its limit position.
The affected systems are advanced continuous-rotation computed tomography systems intended for use in the head and whole body. The recall covers units distributed worldwide, including in the United States (specifically Kentucky, Florida, and St. Croix) and in numerous other countries such as Australia, China, Germany, and Japan.
Healthcare facilities should contact Philips for instructions on how to address the defect. The source text does not specify a remediation method, such as repair or replacement, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
- Category
- Medical Device — CT Systems
- Affected units
- 109
Distribution
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