Philips North America recalled 283 Spectral CT units on January 7, 2026. Fasteners in the device may not be torqued to specification, posing a risk of unsecured rotor parts. While no incidents have been reported, potential safety hazards exist.
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 Spectral CT is a medical imaging device used for diagnostic purposes in healthcare settings. Healthcare providers rely on this equipment for accurate imaging and assessments of patients.
Improperly torqued fasteners may cause the rotor and its parts to become unsecured. This malfunction could lead to serious safety risks if the rotor parts are expelled during operation.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must cease usage of the device, which could disrupt medical procedures and patient care.
Serial numbers can typically be found on the device's identification plate or packaging.
Expect a timeline of 4-6 weeks for processing refunds or replacements once initiated.
Keep records of all communications, including emails and phone calls, along with any receipts or documents related to the purchase.
The recalled product is the Spectral CT with Product Code (REF): 728333. Model numbers include UDI-DI: 00884838101111 and serial numbers ranging from 10055 to 10237. It was distributed worldwide, including across the United States and various countries.
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