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 1.5T SIGNA Artist

  • 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 1.5T SIGNA Artistsee related information
Date Initiated by FirmOctober 09, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0434-2027
Recall Event ID 100210
510(K)NumberK202238 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product1.5T SIGNA Artist, whole body magnetic resonance scanner, System ID 585214MRAO
Code Information GTIN: 00195278117021; Serial Number: PG45S2200367SC
FEI Number 2183553
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3200 N Grandview Blvd
Waukesha WI 53188-1693
For Additional Information ContactJessica Buzek
262-581-7629
Manufacturer Reason
for Recall		Certain protocols can produce incorrect elevated measurements of liver stiffness. These incorrect measurements could contribute to inappropriate clinical management decisions.
FDA Determined
Cause 2		Software design
ActionAn URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/9/26 was sent to customers. Actions to be taken by Customer/User Pending correction by GE HealthCare, you can continue to use your system but do not use the MR Touch protocol to evaluate liver stiffness. If a CX42.0_EA MR Touch protocol was used to evaluate liver stiffness for diagnostic use, if clinically appropriate, rescan those patients with the LX software. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via (FMI 63011 Digital Response Form) or print, fill out manually, scan, and email to Jessica.Buzek@gehealthcare.com. Product Correction GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. Contact Information If you have any questions or concerns regarding this notification, please contact Jessica Buzek at Jessica.Buzek@gehealthcare.com or at +1-262-581-7629.
Quantity in Commerce1 unit
DistributionWorldwide - US Nationwide distribution in the states of NY and the country of Canada.
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
-
-