This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
- Product Names: SENSE XL Torso (1.5T and 3.0T) Coils
- Model: See all affected devices
- Serial Numbers: All serial numbers of the specific SENSE XL Torso (1.5T and 3.0T) coils identified below.
What to Do
- Customers should continue using the identified coils in accordance with the updated Instructions for Use (IFU).
- Avoid First Level Operating Mode/High SAR scans when using these coils.
- Always use dedicated pads and mattresses provided with the coils.
On May 31, 2024, Philips North America LLC sent all affected customers an URGENT Medical Device Recall notice recommending the following actions:
- Review the updated instructions for these devices, which include avoiding positioning the coil close to the bore and not exceeding 45 minutes of examination time.
- Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm.
- Complete and return the attached customer response form to Philips promptly and no later than 30 days from receipt of their letter.
Reason for Updates to Use Instructions
Philips North America LLC is updating use instructions for SENSE XL Torso (1.5T and 3.0T) coils due to a potential issue where the coil heats up during MRI scans, possibly leading to thermal injury.
The use of affected product may cause serious adverse health consequences, including serious burns and death.
There have been 12 reported injuries. There have been no reports of death.
Device Use
The SENSE XL Torso coils (for 1.5T and 3.0T) are 16-element, receive-only coils. The coils include a back part, a front part, and a connection box. This coil is designed for imaging the torso and abdomen. It is used on its own and cannot be combined with other coils. The coils work with 1.5T or 3.0T MR scanners. The coil helps produce diagnostic images of the body, which can be interpreted by a trained physician.
Contact Information
Customers in the U.S. with questions about this recall should contact the Customer Care Solutions Center at 1‐800‐722‐9377, 8AM‐8PM EST, Monday‐Friday.
Full List of Affected Devices
| Product Name | Model |
|---|---|
| SENSE XL TORSO COIL 1.5T | 453567141882 |
| SENSE XL TORSO COIL 1.5T | 453567141883 |
| SENSE XL TORSO COIL 1.5T Mk2 | 453567502281 |
| SENSE XL TORSO COIL 3.0T | 453567394942 |
| SENSE XL TORSO COIL 3.0T | 453567394943 |
| SENSE XL TORSO COIL 3.0T | 453567394945 |
Additional FDA Resources:
FDA’s Enforcement Report
Medical Device Recall Database
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
