Philips SENSE XL Torso Coil Recall Issued Following Reports of Injuries, Burn Risks
Despite multiple burn injuries to users, the manufacturer is not pulling the recalled SENSE XL Torso devices from the market.
Federal safety officials announced a Class I medical device recall for the Philips SENSE XL Torso Coil, after the manufacturer received multiple reports of the coil overheating during scans, potentially leading reports of problems where patients experienced serious burn injuries.
The Philips SENSE XL Torso Coil is a specialized MRI coil designed for imaging the torso region, including the chest, abdomen, and pelvis. It uses SENSE technology to accelerate the imaging process by capturing data simultaneously with multiple coil elements, which improves the signal-to-noise ratio and reduces scan times.
The product provides high-resolution images essential for accurate diagnosis and assessment of conditions related to the heart, lungs, liver, kidneys, and intestines. Additionally, it enhances patient comfort by shortening scan times and is versatile for use in various medical fields, such as cardiology, oncology, and gastroenterology.
The U.S Food and Drug Administration announced the Philips SENSE XL Torso Coil recall on July 8, indicating that the manufacturer is providing updated instructions for using the devices to reduce the risk of the coil unexpectedly overheating during MRI scans. However, the action does not involve removing the device from the market.
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On May 31, 2024, Philips North America LLC issued an URGENT Medical Device Recall notice recommending that customers review the updated instructions, avoid positioning the coil close to the bore, and limit examination time to 45 minutes.
The FDA categorized this as as a Class I recall, which is the most serious type, suggesting that continued use of the product without the updated instructions carries a risk of serious or life-threatening injuries. To date, there have been at least 12 reported injuries, but no deaths have been linked to the recalled coils.
Impacted products include SENSE XL Torso (1.5T and 3.0T) Coils. Customers should follow the updated Instructions for Use (IFU) for the identified coils, avoiding First Level Operating Mode/High SAR scans, and always using the dedicated pads and mattresses provided.
Instructions will be circulated to all device users, to ensure awareness of the issue and associated risks. Customers are also asked to complete and return the attached response form to Philips within 30 days.
U.S. customers with questions about this recall should contact the Customer Care Solutions Center at 1-800-722-9377, available Monday through Friday from 8 AM to 8 PM EST.
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