Z-3023-2017Class II

Optima MR750 3.0T

Name: Z-3023-2017 Optima MR750 3.0T
Creator: GE Medical Systems, LLC
Published: 2017-05-11
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-05-11 / Terminated

FDA source

GE Medical Systems, LLC began a recall of Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to... on 2017-05-11. FDA classified it as Class II and gives the reason as "Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3023-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-11
Posted: 2017-08-02
Terminated: 2020-09-09
Recalling firm: GE Healthcare
Product: Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450 1.5T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
FDA root cause: Mixed-up of materials/components
Action: Consignees received a written recall notice dated 05/17/2017 notifying them of a correction to all units using an Uninterruptable Power Supply. Consignees were instructed not to unplug the unit and to continue normal use. Units with the Eaton 9130 Uninterruptable Power Supply connected to the MR operator console would receive a correction at no charge. This would involve possibly replacing the power cable. GE Representatives will be contacting consignees to arrange corrections. Any questions can be directed to GE Healthcare Service at 1-800-437-1171 or your local service representative.
Quantity in commerce: 68 units in total
Distribution: US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI
Product codes and lots: Medical Device Listing No. D117354, D295466, D182389, D102432, D206140, D230310, D269569, D102430, D140572, D188736, D102434, D234841, D196247, D134019, D236543, D006275, D159181, D288890, D229859; Model No. Eaton 9130, 5323286, 5396502-5, 5499460-3, 5499460-6, 5499460-9, 5741000-3, 00840682115971, 5396502-2, 5499460-2, 5741000-2, 00840682115872, 5373011-3, 5396469-3, 5481490-2, 5481500-7, 5499460-7, 5499460-10, 5741000, 00840682103817, 5323286-101, 2377062-61, 2395001, 2395001-2, 2395001-3, 2395001-4, 00840682105699, 840682105378

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3023-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3021-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11
Z-3022-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11
Z-3023-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11
Z-3024-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11
Z-3025-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11
Z-3026-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11
Z-3027-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11
Z-3028-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11
Z-3029-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)