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 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.
The CT system includes thirty-two fasteners used to attach the rotor to the bearing within the gantry. If these fasteners are not properly torqued, rotor parts may become unsecured, posing a risk of expulsion during operation.
There have been no reported or observed incidents involving expelled parts during gantry rotation. While no injuries have been documented, the hazard level is classified as high.
Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's recall instructions and contact Philips North America for further guidance.
For assistance, contact Philips North America at the number provided in the recall notice. Additional information is available at the FDA recall website.
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