SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
This recall is currently active, issued August 2, 2024. It was issued by Ge Medical Systems, Llc.
- Company
- Ge Medical Systems, Llc
- Recall Initiated
- June 14, 2024
- Posted
- August 2, 2024
- Recall Number
- Z-2461-2024
- Quantity
- 95 units
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
System ID: 501225HEROMR3, 480425MR12, RADNETMR665, 719293MR, 719505MR, RISMR, 678604PHMR, 217258SBMR3T, 508258MR, 406327AMR2, 336760MR2, 402AMI3T, 585922HEROMR, 405601MR2, 843MSEA3T, 713SIGNAHERO1, RADNETMR677, 903758MR3T, 713442KSMR7, 713442FTBNDMR2, 361572HERO, 703797MR1, 832MR000038, 834MR000043, 835MR000031, MR52991481, 083027602496623, 019022MR04, MRAR0023, MRAR0053, 6073MR0059, MRAR0073, MRAR0102, 9668457, 9663364, 8133338, 7361386, 7272696, 7302598, 8425694, 8880017, 6364869, PC2007MR04, H1066MR45, H7270MR01, 083027218333223, 083027807459324, A119731011, A139569302, MR00164, MR00193, MR00194, MR00146, MR00147, MR00182, MR00250, MR00137, MR00183, MR00252, MR00165, MR00247, MR00184, MR00227, 0850270781, 1553MR0067, MRAR0080, MRAR0060, 6073MR0054, DP461335, DPN80004, MP3249110, 849010MR04, 0849010MR04, 222769MR01, 169213MR01, 168934MR01, 752030MR04, 120928MR03, 529150MR03, 529150MR04, 529150MR05, 750100MR04, 1573MR0075, 10197040, 8328819, 7974368, 5973MR0092, 5973MR0082, 5973MR0110, 704384HERO, 083027603761824, GON5452693, MR54353681, MRAR0184, VNMR54373121.
Root Cause
Device Design
Action Taken
GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION to its consignees via letter on 06/14/2024. The letter explained the problem with the device, safety issue, and requested the following: "Actions to be taken by Customer/User: You can continue to use your MR system by following the instructions below: To ensure that the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit specified in the Low SAR Mode User Interface: " If your software version includes the Optimized T2 FLAIR Sequence option, enable this option by setting the value to 1.00. This option is present on the Advanced Tab of the Scan Prescription User Interface. " If your software version does not include the Optimized T2 FLAIR Sequence option, adjust scan parameters such as TR , # Slices or Auto Refocus Flip Angle until the displayed B1+RMS value on the Scan Prescription User Interface does not exceed the user prescribed limit. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.