Philips Ingenuity CT Recall for Emergency Stop Defect
Philips is recalling 172 Ingenuity CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 172 Ingenuity CT Computed Tomography X-Ray systems (Model no. 728326, 728325). The recall is due to a defect where closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
The affected devices are distributed worldwide, including in the United States, Canada, Mexico, and numerous international locations. The recall covers specific serial numbers listed in the agency documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. Patients and consumers should not use the affected equipment until the issue is resolved by the manufacturer.
The recalled product
- Product
- Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 172
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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