FDA recall Z-2467-2024

Product

Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-06-14

Report date

2024-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2467-2024