Lower risk Medical device recall · FDA · Published December 23, 2019

GE Healthcare SIGNA Architect MRI System Date Error Recall

GE Healthcare recalls SIGNA Architect MRI systems that may record incorrect image dates due to installation workflow issues. Affected units need verification and correction to prevent inaccurate medical records.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0875-2020Medical device GE Healthcare ›

Lower-risk 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.

Take action

Contact the company

Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615

✎ GovInfoNow plain-language explainer

GE Healthcare is recalling SIGNA Architect MRI systems that could record incorrect dates on medical images because of a potential installation error. This might lead to inaccurate medical records if not fixed. Read more at govinfonow.com/recall/66216-ge-healthcare-signa-architect-mri-system-date-error-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/66216-ge-healthcare-signa-architect-mri-system-date-error-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0875-2020

Cite this page

“GE Healthcare SIGNA Architect MRI System Date Error Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66216-ge-healthcare-signa-architect-mri-system-date-error-recall. Based on FDA recall #Z-0875-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0875-2020%22&limit=1).

The FDA announced on Dec. 23, 2019, that GE Healthcare LLC recalled its SIGNA Architect Nuclear Magnetic Resonance Imaging Systems due to a potential installation workflow issue causing incorrect system dates and inaccurate image timestamps. The recall affects 62 devices distributed worldwide.

How to tell if you have it

Brand: GE Healthcare
Product: SIGNA Architect Nuclear Magnetic Resonance Imaging System
System IDs: PG75A1700023MR, 630DMGMR3T, 33-4-1252, 312702MR3T, 033-4-1005, 518262MR750W, GON4713311, M4017073, EM0601, O009MR03, GON4634845
Lot/Serial Numbers: To be provided (associated with multiple System IDs)
UPCs: 082427210212, 082427170026

The hazard

According to the FDA, a potential installation workflow issue could cause the MR system date to be set incorrectly. This error results in inaccurate dates recorded on DICOM header information within medical images.

Context

GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since Oct. 4, 2017. Other recent recalls of similar products include GE Healthcare SIGNA Premier MRI Scanners (Feb. 27, 2026), GE Centricity Universal Viewer 6.0/7.0/8.0 (July 15, 2022), and GE Healthcare SIGNA Premier MRI Scanner (June 24, 2022). Additional recent recalls include GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software (July 31, 2026), GE Healthcare Centricity PACS Server V7 (July 31, 2026), and GE Healthcare Enterprise Archive V8 Software (July 31, 2026).

How to tell if you have this one

Check for the system ID codes listed in the recall notice: PG75A1700023MR, 630DMGMR3T, 33-4-1252, 312702MR3T, 033-4-1005, 518262MR750W, 082427210212, 082427170026, GON4713311, M4017073, EM0601, O009MR03, GON4634845.

Brand
GE Healthcare
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
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.

Recall number	Product, codes & lots
Z-0874-2020	SIGNA Premier 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.; Mfg. Lot or Serial# System ID 33-4-1031 415723SHMR19 To be provided RTD01204 To be provided DPN88672
Z-0875-2020	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.; 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
Z-0876-2020	SIGNA Pioneer 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.; Mfg. Lot or Serial # System ID To be provided GON4833100 01264 860536MR3T KZTBL1700064TJ 860871MR3T KZTBL1800069TJ RADNETMR1700 KZTBL1800022TJ 508872PMR 01302 RADNETMR1708 KZTBL1900130TJ 301698MR1 KZTBL1900071TJ 704333PIO KZTBL1900110TJ 631751MR KZTBL1900107TJ RADNETMR1707 KZTBL1900121TJ 803936LMCMR2 033-4-1532 281HMI750W To be provided 83199160995 To be provided M24313812 To be provided M2850013 To be provided TP0013MR01 To be provided PNUE04MR02 To be provided TP0008MR07 To be provided 083027823408018 To be provided 083027823888617 To be provided GON4826677 To be provided GON4762453 To be provided B5142305 To be provided ZC0002 To be provided ZC0034 To be provided ZC0001 To be provided ZC0306 To be provided GON4795546 To be provided 222768MR01 To be provided 34340MRS02 To be provided 10627MRS02
Z-0877-2020	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.; 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

Based on the official FDA remedy

What to do — step by step

Verify System ID
Check the system ID codes listed in the recall notice to confirm if your SIGNA Architect MRI system is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Dec 23, 2019Firm started the recall
Jan 28, 2020FDA classified it Class II
Feb 5, 2020Published in FDA’s Enforcement Report
Dec 11, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66216-ge-healthcare-signa-architect-mri-system-date-error-recall">GE Healthcare SIGNA Architect MRI System Date Error Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0875-2020 (December 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0875-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.