Recall – MRI image slices missing

Company: GE Healthcare, LLC
Date of Enforcement Report: 10/27/2021
Class II

PRODUCT

SIGNA Premier

Recall Number: Z-0132-2022

SIGNA Architect

Recall Number: Z-0133-2022

SIGNA Pioneer

Recall Number: Z-0134-2022

Discovery MR750w 3.0T

Recall Number: Z-0135-2022

Discovery MR750 3.0T

Recall Number: Z-0136-2022

SIGNA Creator, SIGNA Explorer

Recall Number: Z-0137-2022

SIGNA Voyager

Recall Number: Z-0138-2022

SIGNA Artist

Recall Number: Z-0139-2022

Optima MR450w 1.5T

Recall Number: Z-0140-2022

1.5T SIGNA HDxt MR System

Recall Number: Z-0141-2022

 

REASON

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

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 8/26/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

11 devices

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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