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Philips Issues Urgent Medical Device Recall for SENSE XL Torso Coils

Philips North America LLC has issued an urgent recall notice for all models and serial numbers of its SENSE XL Torso (1.5T and 3.0T) coils due to a potential safety issue where the coil can overheat during MRI scans, leading to risks of thermal injury.

Customers are advised to adhere strictly to the newly updated Instructions for Use (IFU). The key guidelines include avoiding the First Level Operating Mode/High SAR scans and using only the dedicated pads and mattresses provided. The IFU also warns against positioning the coil close to the MRI bore and limits examination time to 45 minutes to prevent overheating.

This recall, effective as of May 31, 2024, follows 12 reported injuries linked to the use of these devices, though no deaths have been reported. The SENSE XL Torso coils, which cannot be used in conjunction with other coils, are specialized for imaging the torso and abdomen with 1.5T or 3.0T MR scanners.

The recall notice includes a directive for all users of the device to review the safety updates and circulate the information among potential users. Philips has also requested the return of a customer response form within 30 days of the notice.

For further assistance, U.S. customers can contact the Philips Customer Care Solutions Center at 1-800-722-9377, available from 8 AM to 8 PM EST, Monday through Friday.

The FDA has classified this as a Class 1 recall, indicating that the use of these products could cause serious adverse health consequences or death. For more details, customers can refer to the FDA’s Medical Device Recall Database and the Enforcement Report links provided in the notice.

Philips stresses the importance of the Unique Device Identifier (UDI) system in tracking and managing medical devices efficiently. Users can report any adverse reactions or quality issues to the FDA’s MedWatch program.

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