Tuesday, July 16, 2024

MRI Scan Safety Update: Philips Revises Guidelines for SENSE XL Torso Coils to Prevent Thermal Injuries

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Philips North America LLC has updated the use instructions for its SENSE XL Torso coils due to potential heating issues during MRI scans. The revised guidelines aim to prevent thermal injuries, and this update is crucial as continued use without following the new instructions may cause serious injury or death. This recall involves changing the use instructions rather than removing the devices from service.

The affected products are the SENSE XL Torso coils, which include all serial numbers of these specific models. These devices are designed to image the torso and abdomen using 1.5T or 3.0T MRI scanners. These coils are 16-element, receive-only devices and must be used independently, not in combination with other coils. They consist of a back part, a front part, and a connection box, which helps produce diagnostic images that physicians can interpret. The primary purpose of these coils is to aid in accurately diagnosing conditions affecting the torso and abdomen, making them a vital tool in medical imaging.

Philips Urges Customers to Follow Updated MRI Scan Safety Instructions

Customers should continue to use the coils following the updated Instructions for Use (IFU). Key safety measures include avoiding First Level Operating Mode/High SAR scans with these coils and always using dedicated pads and mattresses provided with the coils. Following the updated guidelines supplied on May 31, 2024, is essential, which includes keeping the coil away from the bore and limiting examination time to 45 minutes. Philips North America LLC sent an URGENT Medical Device Recall notice to all affected customers, recommending several actions to ensure safety.

Firstly, customers should review the updated use instructions thoroughly. These instructions provide detailed steps on how to safely operate the coils and prevent overheating. Secondly, the notice should be circulated to all device users to ensure awareness of the potential issue and associated risks. This helps in making sure that everyone involved in using the device is informed and can take necessary precautions. Lastly, customers are required to complete and return the customer response form to Philips within 30 days of receiving the notice. This response helps Philips to track compliance and ensure that the updated instructions are being followed.

MRI Scan

Philips SENSE XL Torso Coils Heating Issue Prompts Critical Safety Update

The reason for these updates is due to the discovery that the SENSE XL Torso coils can heat during MRI scans, potentially leading to thermal injuries. There have been 12 reported injuries linked to this issue, although no deaths have been reported. The use of these affected products may cause serious adverse health consequences, including serious burns and death. The FDA has classified this recall as the most serious type, indicating a risk of serious injury or death if the updated instructions are not followed.

The SENSE XL Torso coils are essential for producing diagnostic images of the torso and abdomen, aiding physicians in interpreting medical conditions. They are specifically designed for 1.5T and 3.0T MRI scanners, playing a critical role in diagnostic imaging. These coils help produce high-quality images that are crucial for accurate diagnosis and treatment planning. Ensuring these devices are used safely and effectively is paramount to patient health and safety. Philips’ proactive steps in updating the instructions and ensuring widespread communication about these updates underscore the importance of patient safety and adherence to proper usage guidelines.

 

Resource: Food and Drug Administration, July 08, 2024

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