The FDA has labeled Philips’ recall of some Sense XL Torso Coils as Class I, the most serious kind.
Royal Philips (NYSE:PHG) has recalled all serial numbers of specific Sense XL Torso (1.5T and 3.0T) coils due to a potential issue with the coil heating up during MRI scans, which could lead to thermal injury. The recall involves updating the instructions for use and does not involve removing the coils from where they are used or sold.
The Sense XL Torso coils are 16-element, receive-only coils. They include a back part, a front part and a connection box that work together to image the torso and abdomen. The coils cannot be combined with other coils and can only be used independently. They work with 1.5T or 3.0T MR scanners to help produce diagnostic images of the body that can be interpreted by a trained physician.
Philips notified customers of this potential issue in June. The company said in a statement to MassDevice that the recall affects 1,050 units worldwide. There have been 12 reported injuries and no reports of death, according to the FDA.
“Affected units may continue to be used in accordance with device instructions for use, and the notification letter. In addition to the field safety notice, Philips anticipates providing an update to customers regarding a projected correction by the end of 2024,” Philips said in an emailed statement to MassDevice.
The company also recommends avoiding first-level operating mode/high SAR scans when using these coils and always using dedicated pads and mattresses provided with the coils. Updated instructions also include avoiding positioning the coil close to the bore and not exceeding 45 minutes of examination time.
Here are the specific devices affected by the recall:
