SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Recall #Z-2479-2024 — Class II — June 14, 2024
Product Description
SIGNA Prime, with affected software versions: MR30.1; 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.
Recalling Firm
GE Medical Systems, LLC — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
72 units
Distribution
Worldwide distribution.
Code Information
System ID: 662335PRIME, DZ2423MR01, DZ4388MR01, DZ3836MR01, MR6345AR, MR8657AR, MR1612AR, MR3084AR, MR7154AR, MRPM0464, MR51928141, 8.30276E+13, 8.30276E+13, MRPM1206, MRPM0798, MRPM0933, MRPM1282, MRPM0601, MRPM0960, MRPM0944, MRPM0725, MRPM1207, MRPM1287, MRPM1247, MRPM1226, MRPM1250, MRPM1175, MRPM1036, MRPM0658, MRPM0726, MRPM1309, MRPM0762, MRPM0420, MRPM0673, 082427290074, MR2427CO, MR8526CO, MRPM1310, MRPM1149, MRPM1298, MRPM1297, MRPM0841, MRPM1192, MRPM1268, MRPM0936, MRPM0547, EG1070MR02, MRPM1286, MRPM1201, 8.30278E+13, 8.30279E+13, 083027808226922, 7982MR0077, 7982MR0090, MR52529514, MR52529501, MR53615221, MR51674971, 8554396, NG1233MR01, MR51557681, NG1950MR01, MR5239828, 1557MR0056, 1557MR0058, MRPM0888, 8109195, 8154038, 9082439, 8033622, 9830MR0115, 1557MR0065.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated