Z-0859-2022Class II

SIGNA Excite 3T. Magnetic Resonance Imaging System

Name: Z-0859-2022 SIGNA Excite 3T. Magnetic Resonance Imaging System
Creator: GE Healthcare, LLC
Published: 2022-02-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-02-18 / Open, Classified / root cause: design

FDA source

GE Healthcare, LLC began a recall of SIGNA Excite 3T. Magnetic Resonance Imaging System on 2022-02-18. FDA classified it as Class II and gives the reason as "There is potential for the images to be flipped left to right". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0859-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-18
Posted: 2022-04-04
Recalling firm: GE Healthcare
Product: SIGNA Excite 3T. Magnetic Resonance Imaging System
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: There is potential for the images to be flipped left to right.
Root cause tag: design
FDA root cause: Device Design
Action: This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected systems. This 2/18/2022 letter informs the customer of the issue and provides actions to be taken for the continued use of the device. GE Healthcare will provide a revised service manual that includes a required Finalization step that ensures a geometry check with a DQA phantom (or similar) following Gradient Switch servicing to ensure cable placement is correct and will have no impact on image orientation. A second letter was send to customers on 07/27/2022 and included instructions and link for customer to access and download the revised service manual.
Quantity in commerce: 55 units
Distribution: Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: System IDs: 3422, 209577MRMOBX, 407303CHMR, SIMONVILLAGES3T, 321MR3T3, 321MR3T2, 407999MR3T, 316268TWIN3, 8109873T, 732473MR, 702433SIM3T, 864573MBMR2, 901726OPMR, 214879INVIVO, 817578LGMR2, 972665XDDAMR1 2284SIG15T, 47413, 2550000, 975, 604270MR3T, 416813MR3, 416369MR2, 082427130025 082427130020, 082427130022, 082427270012, 082427270011, 082427150025, 082427020020, 082427010032, 082427160051, 082427160050, 082427120042, 082427120027, 082427030037, 082427250016, 082427070046, 082427150026, 082427090035, 082427140034, 082427140040, 082427090044, 082427100075, 082427120029, 082427070049, 082427070048, 082427220010, 082427300008, YM1408, YM1414, YM1406, 850270152, LB1049MR02, PK1184MR01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0859-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0857-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-04
Z-0858-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-04
Z-0859-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-04
Z-0860-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-04

Product code LNH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)