1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Reported: October 27, 2021 Initiated: August 26, 2021 #Z-0141-2022
Product Description
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Reason for Recall
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 3 devices
- Distribution
- Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system. Recalled by GE Healthcare, LLC. Units affected: 3 devices.
Why was this product recalled? ▼
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0141-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11