Philips Updates Sense XL Torso Coil Use Instructions

Philips North America’s recall of its Sense XL Torso Coils recently got upgraded to Class I as a correction, not a product removal, as the company rolls out use instruction updates to mitigate thermal injury risk during MRI scans.

The Sense XL Torso Coils (for 1.5T and 3.0T) are 16-element, receive-only coils which include a back part, a front part, and a connection box. The coil is designed for imaging the torso and abdomen. Used to work with 1.5T and 3.0T MR scanners, the coils help produce diagnostic images of the body.

Philips is updating its use instructions for the coils after reports of a potential issue where it heats up during MRI scans, possibly leading to thermal injuries like serious burns.

On May 31, the company sent all affected customers an Urgent Medical Device Recall notice recommending that all users review the updated instructions for the device, which includes avoiding positioning the coil close to the bore and not exceeding 45 minutes of examination time. Additionally, it is recommended that customers continue using the identified coils in accordance with the updated instructions, avoiding first level operating mode and high SAR scans when using the device, and always using dedicated pads and mattresses provided with the coils.

There have been 12 reported injuries and no deaths connected to the recall.