Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SIGNA Hero

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall SIGNA Herosee related information
Date Initiated by FirmJune 14, 2024
Date PostedAugust 02, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2461-2024
Recall Event ID 94874
510(K)NumberK213668 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductSIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Code Information 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
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3200 N Grandview Blvd
Waukesha WI 53188-1693
For Additional Information Contact
262-521-6560
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionGE 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.
Quantity in Commerce89 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LNH
-
-