FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: 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.
- Recall number
- Z-1100-2013
- Recalling firm
- GE Healthcare, LLC
- 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.
- Status
- Terminated
- Initiated
- 2012-04-23
- Posted
- 2013-04-11
- Terminated
- 2014-03-14
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- K103327
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28