SIGNA Voyager nuclear magnetic resonance imaging system recallZ-0138-2022 · GE Healthcare, LLC · initiated Aug 26, 2021
Class II Terminated All recalls posted in October 2021
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0138-2022
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 26, 2021
- Posted by the FDA
- Oct 16, 2021
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 15 devices
- Product code
- LNH
- FDA submissions
- K161567, K192426
- 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
Product description
SIGNA Voyager nuclear magnetic resonance imaging system
Code information (models, lots, serial numbers)
Software version VX29.1; and PX26.4 (China only)
Other devices under the same FDA submission
1 device cleared under K161567, K192426 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA SIGNA VoyagerGe Healthcare(Tianjin) Company Limited · System, nuclear magnetic resonance imaging1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 88665).
- Z-0132-2022 · TerminatedSIGNA Premier nuclear magnetic resonance imaging system
- Z-0133-2022 · TerminatedSIGNA Architect nuclear magnetic resonance imaging system
- Z-0134-2022 · TerminatedSIGNA Pioneer nuclear magnetic resonance imaging system
- Z-0135-2022 · TerminatedDiscovery MR750w 3.0T nuclear magnetic resonance imaging system
- Z-0136-2022 · TerminatedDiscovery MR750 3.0T nuclear magnetic resonance imaging system
- Z-0137-2022 · TerminatedSIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
- Z-0139-2022 · TerminatedSIGNA Artist nuclear magnetic resonance imaging system
- Z-0140-2022 · TerminatedOptima MR450w 1.5T nuclear magnetic resonance imaging system
- Z-0141-2022 · Terminated1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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