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SIGNA Architect nuclear magnetic resonance imaging system recallZ-0133-2022 · GE Healthcare, LLC · initiated Aug 26, 2021

Class II Terminated All recalls posted in October 2021

Is my device affected?

  1. 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.
  2. 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.
  3. 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-0133-2022
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
2 devices
Product code
LNH
FDA submissions
K160618, K163331, K202966
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 Architect nuclear magnetic resonance imaging system

Code information (models, lots, serial numbers)

Software version DV29.1; and   DV28.4 (F), DV27.3 (T) (China only)

Other devices under the same FDA submission

10 devices cleared under K160618, K163331, K202966 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88665).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page