SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Class II · Ongoing
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.
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Affected lots / codes — check yours against thisSystem ID: GON5374156, DZ4952MR01, MRPM1180, MRR8022, MRPM0474A, MRPM1267, MRR8322, MRPM0795, MRPM1093, FI1271MR01, XM9192701, MR53305381, 397480MR01, PC7479MR04, H6383MR02, MR00226, MR00207, 1553MR0071, PPS79502, SA2215MR01, GON5419122, GON5435507, 9761071
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- 23 units
- Distribution
- Worldwide distribution.
- Recall initiated
- June 14, 2024
- Classified
- August 2, 2024
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2480-2024%22
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2480-2024%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
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