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Philips issues recall for SENSE XL torso MR coil due to potential overheating risk

by Gus Iversen, Editor in Chief | July 01, 2024
MRI
Philips North America LLC has initiated a Class 1 device recall for its SENSE XL Torso Coil 1.5T Mk2, citing a risk of overheating that could potentially harm patients. The recall, identified under number Z-2165-2024, was initiated on June 5, 2024, and made public on June 27, 2024.

The SENSE XL Torso Coil, a 16-element receive-only coil used for torso and abdomen imaging in Philips MR Intera and Achieva Systems, has been flagged for its potential to heat up, posing a burn risk to patients. The recall impacts models with serial numbers including 190, 187, 71, 60, 39, 24, 244, 36, 184, 151, 185, 245, 179, and 29.

The Cambridge, Massachusetts-based company identified the device design as the root cause of the issue. In response, Philips has issued an URGENT MEDICAL DEVICE RECALL notice to consignees, dated May 31, 2024. This notice includes specific operational instructions to mitigate the risk, such as avoiding the First Level Operating Mode/High Specific Absorption Rate (SAR) scans, using dedicated pads and mattresses provided with the coils, maintaining a distance of at least two inches (5 cm) from the bore, and limiting examination time to no more than 45 minutes. Additionally, an advisory notice summarizing these recommended actions was included with the recall notification and should be displayed with affected systems to ensure access by operators.
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Philips is actively developing field corrections to address the issue, which may include software risk control measures to limit scan settings, hardware updates, and design improvements for the coil. The company plans to update consignees on these actions by the end of 2024.

The recall affects 14 units distributed worldwide, including in the United States and numerous other countries such as Afghanistan, Argentina, Australia, and many more.

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