Recall Z-2482-2024— GE Medical Systems, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2024-06-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only. Reason: 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..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-14
- Firm location
- Waukesha, WI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.