Philips North America recalled 52 units of the IQon Spectral CT on January 7, 2026, due to fasteners that may not be torqued to specification. This defect may lead to unsecured rotor parts during operation. No injuries have been reported, but the potential for parts to be expelled during gantry rotation poses a safety risk.
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter
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The IQon Spectral CT is a medical imaging device used for detailed imaging in various healthcare settings. It is often employed in diagnostic procedures to assist healthcare professionals in evaluating patient conditions.
If the fasteners that secure the rotor are improperly torqued, there is a risk that rotor parts may become unsecured, which could lead to parts being expelled during operation, posing a serious safety hazard.
This recall is not part of a broader industry pattern.
The recall affects the operational safety of medical imaging procedures. Healthcare facilities must cease use of the affected units, which could lead to temporary disruption in diagnostic services.
The product code and serial numbers can typically be found on the back or underside of the device, near the power supply.
Expect a refund processing timeline of approximately 4-6 weeks after following the recall instructions.
Keep records of all communications with Philips, including emails, letters, and phone call notes.
The recalled product is the IQon Spectral CT, Product Code (REF): 728332. It was distributed worldwide, including across 15 states in the U.S. and several countries, with a total of 52 units affected.
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