MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504),

FDA device recall Z-2041-2024 · posted 2024-06-09 · Open, Classified

Recall details

Recalling firm

Canon Medical System, USA, INC.

Reason for recall

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.

Action taken

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 pbiggins@us.medical.canon For questions, please contact our InTouch team at intouchdispatch@us.medical.canon

Root cause

Device Design

Status

Open, Classified

Product code

LNH

Quantity affected

153

Distribution

US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ, IL, OK, CA, FL, GA, OR, IN, NJ, CO, MT, KS, MO, WY, VA, VT, LA, NH, WV, TN, PR

Date initiated

2024-05-10

Date posted

2024-06-09

Location

Tustin, CA

Related 510(k) clearances