GE Healthcare, LLC: Medical Device Recall in 2020 - (Recall #: Z-0877-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Product Classification:

Class II

Date Initiated: December 23, 2019

Date Posted: February 5, 2020

Recall Number: Z-0877-2020

Event ID: 84655

Reason for Recall:

It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

Status: Terminated

Product Quantity: 62 (30 US, 32 OUS) total devices

Code Information:

Mfg. Lot or Serial # System ID 22D-4-0868 901BMHCRITMR HDGOC1900010SC 209521SGMR HDGOC1900015SC 4577711MR11 002776WHF 954916MR1 022D-4-1175 808243MR 857 LONGWOOD30MR2 00000290815MR0 508580BMR3 002801WHF 734246MR 002930WHF 845279MR 00000269040MR2 412749MR1 022D-4-1125 801RIVMR2 HDGOC1900003SC 206386SMR H05114 4815915MR11 00000277443MR8 304526SMR1 To be provided GON4796599 To be provided 424881MR01 To be provided 083027829345912 To be provided 083027862100408

Distribution Pattern:

Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated