GE Medical Systems, LLC: Medical Device Recall in 2024 - (Recall #: Z-2480-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

Product Classification:

Class II

Date Initiated: June 14, 2024
Date Posted: August 14, 2024
Recall Number: Z-2480-2024
Event ID: 94874
Reason for Recall:

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Status: Ongoing
Product Quantity: 23 units
Code Information:

System ID: GON5374156, DZ4952MR01, MRPM1180, MRR8022, MRPM0474A, MRPM1267, MRR8322, MRPM0795, MRPM1093, FI1271MR01, XM9192701, MR53305381, 397480MR01, PC7479MR04, H6383MR02, MR00226, MR00207, 1553MR0071, PPS79502, SA2215MR01, GON5419122, GON5435507, 9761071

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated