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 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.
Thirty-two fasteners attach the rotor to the bearing within the gantry. If these fasteners are not properly torqued, the rotor parts could become unsecured, potentially leading to expulsion during operation.
There have been no reported incidents of expelled parts during gantry rotation. However, the potential for unsecured rotor parts presents a significant safety concern.
Patients and healthcare providers should stop using the device immediately. Contact Philips North America or your healthcare provider for further instructions.
For assistance, call Philips North America or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1317-2026.
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