Philips Issues Urgent Medical Device Recall for SENSE XL Torso Coils

Philips North America LLC has announced an urgent recall of all SENSE XL Torso coil models and serial numbers (1.5T and 3.0T) due to a potential safety risk in which the coil may overheat during MRI scanning, potentially leading to a risk of thermal injury.

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

This recall, effective May 31, 2024, follows 12 reported injuries associated with the use of these devices, although 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 using 1.5T or 3.0T MR scanners.

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

For further assistance, U.S. customers can contact the Philips Customer Care Center at 1-800-722-9377, open 8:00 a.m. to 8:00 p.m. Eastern Time, Monday through Friday.

The FDA has classified this as a Class 1 recall, meaning that use of these products could cause serious adverse health effects or death. For more details, customers can review the FDA Medical Device Recall Database and the enforcement report links provided in the notice.

Philips emphasizes 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.