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.
FDA Recall Z-1100-2013 · Posted 2013-04-11
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2012-04-23
Date Terminated2014-03-14
Product Quantity46
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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