MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
Recall
- Recall Number
- Z-2041-2024
- Event Number
- 94609
- Firm
- Canon Medical System, USA, INC.
- FEI Number
- 2020563
- Product Code
- LNH
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- May 10, 2024
- Posted
- June 9, 2024
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047
Description
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020)
The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.
On 5/10/24, correction notices were sent to customers who were asked to do the following: 1) The replacement of the power cable securing parts that may cause smoke and fire, with parts made of materials with a higher degree of flame retardance, is now being released. 2) A firm representative will contact you to schedule a time to replace the power cable securing parts. 3) If any abnormalities such as unusual smells or smoke are observed before the work, immediately stop using the system and contact your service representative. 4) The parts required to address the defect are expected to be available no earlier than June 2024. 5) Complete and return the reply form via DocuSign or via email to [email protected] For questions, please contact our InTouch team at [email protected]
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