Z-0877-2020Class II

SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi -

Name: Z-0877-2020 SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi -
Creator: GE Healthcare, LLC
Published: 2019-12-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-12-23 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of 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... on 2019-12-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0877-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-23
Posted: 2020-01-28
Terminated: 2020-12-11
Recalling firm: GE Healthcare
Product: 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 code: LNH System, Nuclear Magnetic Resonance Imaging
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.
Root cause tag: software
FDA root cause: Software design
Action: This issue will be resolved by sending an Urgent Medical Device Correction letter to Medical Facility staff (Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering) with affected systems. This letter will inform the customer of the issue and instruct the user to ensure the displayed system date is correct. The long-term solution is to correct affected systems with updated software.
Quantity in commerce: 62 (30 US, 32 OUS) total devices
Distribution: Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0877-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0874-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-28
Z-0875-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-28
Z-0876-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-28
Z-0877-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-28

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)