FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: SIGNA Artist nuclear magnetic resonance imaging system
- Recall number
- Z-0139-2022
- Recalling firm
- GE Healthcare, LLC
- Product
- SIGNA Artist nuclear magnetic resonance imaging system
- Status
- Terminated
- Initiated
- 2021-08-26
- Posted
- 2021-10-16
- Terminated
- 2026-05-04
- Reason
- Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- Root cause
- Software design
- Action
- GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
- Quantity
- 18 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
- Lot, serial or model codes
- Software version DV29.1
- 510(k) numbers
- ["K160618","K163331","K202238"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28