The Recall Desk
HighFDA (Devices)·Z-1405-2018·Announced 2018-04-25

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.

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 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
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.

See all 12 products in this recall →