| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00597-1 |
| Product Name/Description |
Philips SENSE XL Torso (1.5T and 3.0T) Coils
SENSE XL TORSO COPIL 1.5T
Model: 453567141882, 453567141883
SENSE XL TORSO COIL 1.5T Mk2
Model: 453567502281
SENSE XL TORSO COIL 3.0T
Model: 456567394942, 456567394943, 456567394945
ARTG 425091
(Philips Electronics Australia Ltd - Coil, MRI, radio frequency) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified a problem in the SENSE XL Torso (1.5T and 3.0T) coils which may result in localised heating during the scan, resulting in potential for a heating sensation and/or 1st, 2nd or 3rd degree burns around the area covered by the coil.
Philips has received 64 complaints of coil heating events, including 52 reports of patient harm associated with this issue as of April 2024. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are able to continue use of the coils in accordance with the Instructions for Use (IFU).
1. Avoid First Level Operating Mode/High SAR scans
2. Use dedicated pads - Always use dedicated pads and mattresses provide with the coils.
In addition:
1. Avoid positioning the coil close to the bore
When using the SENSE XL (1.5T and 3.0T) Torso Coils, ensure the anterior portion of the coil is positioned greater than 2 inches (5 cm) away from the bore.
2. Do not exceed 45 minutes of examination time (excluding setup time) for a single patient.
Philips is also initiating design of an improved coil. An update on the development of this plan is expected to be relayed by the end of 2024. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |