Philips Ingenuity Flex CT Scanner Recall for Emergency Stop Defect
Philips is recalling 151 Ingenuity Flex CT scanners because closing the Emergency Stop may disable the horizontal motor, allowing the couch 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 mechanical defect that could cause injury to patients during loading or unloading, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 151 units of the Ingenuity Flex Computed Tomography X-Ray system, Model no. 728317. The recall was initiated because closing the Emergency Stop may disable the horizontal motor, which allows the couch top to move during patient load or unload activities.
The affected devices were distributed worldwide, including in the United States, Canada, Mexico, and numerous international locations. The specific serial numbers for the 151 affected units are listed in the agency's recall record.
Healthcare facilities should contact Philips Medical Systems to arrange for the necessary corrective actions to ensure the safety of the equipment during patient handling.
The recalled product
- Product
- Ingenuity Flex - Model no. 728317, 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 device
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 151
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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