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