Z-1100-2013Class II

GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293

Name: Z-1100-2013 GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293
Creator: GE Healthcare, LLC
Published: 2012-04-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-04-23 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial... on 2012-04-23. FDA classified it as Class II and gives the reason as "GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding...". 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-1100-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-23
Posted: 2013-04-11
Terminated: 2014-03-14
Recalling firm: GE Healthcare
Product: GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: 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.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare sent an Important Product Information letter dated April 23, 2012. The letter described the Issue, Instructions, Affected Product Details and Product Correction. For questions contact your local service representative.
Quantity in commerce: 46
Distribution: Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, IL, MD, NJ, NY, OH, OK, TX. and the countries of Australia, Belarus, Canada, France, Germany, India, Japan, Lebanon, New Zealand, Saudi Arabia, Singapore, Spain, Sweden, Switzerland and United Kingdom.
Product codes and lots: Serial Number 00000000UA0027 00000000UA0012 00000000UA0029 00000000UA0031 00000000UA0030 00000000UA0028 00000000UA0034 00000000UA0038 00000000UA0048 00000000UA0046 00000000UA0052 00000000UA0041 00000000UA0011A 00000000UA0055 00000000UA0056 00000000UA0057 00000000UA0064 00000000UA0053 00000000UA0044 00000000UA0047 00000000UA0010 00000000UA0013 00000000UA0017 00000000UA0042 00000000UA0016 00000000UA0019 00000000UA0015 00000000UA0058 00000000UA0051 00000000UA0025 00000000UA0024 00000000UA0020 00000000UA0040 00000000UA0018 00000000UA0036 00000000UA0043 00000000UA0054 00000000UA0022 00000000UA0023 00000000UA0045 00000000UA0039 00000000UA0035 00000000UA0049 00000000UA0021 00000000UA0033 00000000UA0037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1100-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1100-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-11

Product code LNH

K103327Class IIDiscovery Mr750w 3.0TGe Healthcare Japan Corporation / cleared 2011-09-30

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)