Recalls / —

—#189212

Product

SIGNA Artist nuclear magnetic resonance imaging system

FDA product code

LNH — System, Nuclear Magnetic Resonance Imaging

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K160618, K163331, K202238

Affected lot / code info

Software version DV29.1

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated

2021-08-26

Posted by FDA

2021-10-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #189212. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.