Philips Ingenuity Core CT Systems Recalled for Couch Movement Hazard
Philips is recalling 281 Ingenuity Core CT systems because the emergency stop may fail to lock the couch, allowing it to move during patient loading.
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 hazard involves a risk of physical injury (couch movement) during patient handling, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 281 units of the Ingenuity Core Computed Tomography (CT) X-Ray system, Model no. 728321. The recall covers units distributed worldwide, including the United States, Canada, Mexico, and numerous international markets.
The recall is due to a defect where closing the Emergency Stop may fail to disable the horizontal motor. This failure allows the couch top to move during patient load or unload activities, posing a risk of injury to patients or staff.
Healthcare facilities should contact Philips Medical Systems to arrange for a repair or replacement. Consumers should not use the affected equipment until the issue is resolved by the manufacturer.
The recalled product
- Product
- Ingenuity Core - Model no. 728321, 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 devices
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 281
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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