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Terminated

SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

FDA Recall Z-0137-2022 · Posted 2021-10-16

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2021-08-26
Date Terminated2026-05-04
Product Quantity6 devices

Reason for Recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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