Philips North America recalled three Spectral CT 7500 units on January 7, 2026. The recall affects models with potential fastener issues that could lead to unsecured rotor parts. Patients and healthcare providers should stop using the device immediately.
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 7500 with Product Code (REF): 728334. The affected units were distributed worldwide, including states such as California and New York, and countries like Germany and Australia.
Thirty-two fasteners attach the rotor to the bearing within the gantry. If these fasteners are not torqued to specification, the rotor may become unsecured, posing a high risk of parts being expelled during operation.
There have been no reported incidents of expelled parts during gantry rotation. The risk of unsecured rotor parts being expelled remains a serious concern.
Patients and healthcare providers should immediately stop using the Spectral CT 7500. Contact Philips North America for further instructions and follow the recall instructions provided.
Contact Philips North America at the customer service number available on their website. Further details can be found at the FDA's recall page.
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