Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Philips recall of imaging coils associated with 12 injuries

Philips has recalled several models of its Sense XL Torso coils due to the risk of overheating during MRI scans, which can cause burns to patients. The FDA's recall notice includes updated instructions for six models used with 1.5T and 3.0T MRI scanners. The recall does not require product removal from facilities.

Twelve injuries have been reported, but no deaths. This recall adds to Philips' ongoing safety issues, including the recall of over 15 million respiratory devices and recent problems with imaging machines. In November, Philips recalled certain MRI scanners due to explosion risks, with one incident reported in 22 years. In February, the FDA issued a warning for unreported field corrections for CT machines.

The recall, initiated on June 5, affects over 1,000 devices worldwide. Philips advised customers to avoid positioning coils close to the machine’s bore, limit examination time to 45 minutes, and use dedicated pads and mattresses. The FDA classified the recall as a Class I event due to severe burn risks.