Z-0140-2022Class II

Optima MR450w 1.5T nuclear magnetic resonance imaging system

Name: Z-0140-2022 Optima MR450w 1.5T nuclear magnetic resonance imaging system
Creator: GE Healthcare, LLC
Published: 2021-08-26
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-08-26 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of Optima MR450w 1.5T nuclear magnetic resonance imaging system on 2021-08-26. FDA classified it as Class II and gives the reason as "Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images". 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-0140-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-26
Posted: 2021-10-16
Terminated: 2026-05-04
Recalling firm: GE Healthcare
Product: Optima MR450w 1.5T nuclear magnetic resonance imaging system
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Root cause tag: software
FDA root cause: Software design
Action: GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Quantity in commerce: 13 devices
Distribution: Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK
Product codes and lots: Software version DV29.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0140-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0132-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0133-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0134-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0135-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0136-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0137-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0138-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0139-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0140-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0141-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-16

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)