Philips North America recalled 47 CT scanners on January 7, 2026, due to improperly torqued rotor fasteners. This issue could lead to unsecured rotor parts, posing a high risk during operation. Patients and healthcare providers must 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 Brilliance iCT CT Scanner is used for imaging in various medical settings. It is crucial for diagnostic purposes and patient care, making its reliability essential.
The fasteners securing the rotor to the bearing may not be properly tightened, leading to a risk of rotor parts becoming unsecured and potentially causing serious incidents during operation.
This recall is not part of a broader industry pattern.
The recall necessitates immediate action from healthcare providers, impacting patient care and potentially leading to equipment downtime.
Serial numbers can typically be found on the back or bottom of the device, often near the power supply or on a label.
Expect processing times for refunds or replacements to be approximately 4-6 weeks.
Keep records of all correspondence regarding the recall, including emails and phone call notes.
The recall affects the Brilliance iCT model with Product Code (REF): 728306. It was sold worldwide, including in several U.S. states and various countries. The recalled units were distributed between the product's manufacturing date and the recall date.
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