Philips IQon Spectral CT Recalled for Emergency Stop Defect
Philips is recalling 47 IQon Spectral CT systems 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential physical injury during patient handling.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 47 IQon Spectral CT systems, model number 728332. These are computed tomography X-ray systems intended to produce cross-sectional images of the body.
The recall is due to a defect where closing the emergency stop may disable the horizontal motor. This could allow the couch top to move during patient load or unload activities.
The affected units were distributed worldwide, including the United States and numerous international locations. Specific serial numbers for the 47 units are listed in the recall documentation. Users should contact the manufacturer for instructions on how to address the defect.
The recalled product
- Product
- IQon Spectral CT - Model no. 728332, 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 devi
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 47
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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