PlainRecalls
FDA Devices Moderate Class II Ongoing

Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

Reported: August 14, 2024 Initiated: June 14, 2024 #Z-2482-2024

Product Description

Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

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.

Details

Recalling Firm
GE Medical Systems, LLC
Units Affected
1 unit
Distribution
Worldwide distribution.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only. Recalled by GE Medical Systems, LLC. Units affected: 1 unit.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 14, 2024. Severity: Moderate. Recall number: Z-2482-2024.