Z-0875-2020Class II

SIGNA Architect Nuclear Magnetic Resonance Imaging System -

Name: Z-0875-2020 SIGNA Architect Nuclear Magnetic Resonance Imaging System -
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 Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high... 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-0875-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-23
Posted: 2020-01-28
Terminated: 2020-12-11
Recalling firm: GE Healthcare
Product: SIGNA Architect Nuclear Magnetic Resonance Imaging System - 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 PG75A1700023MR 630DMGMR3T 33-4-1252 312702MR3T 033-4-1005 518262MR750W To be provided 082427210212 To be provided 082427170026 To be provided GON4713311 To be provided M4017073 To be provided EM0601 To be provided O009MR03 To be provided GON4634845

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0875-2020
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

K163331Class IIDiscovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA ArtistGe Medical Systems, LLC / cleared 2017-03-17

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)