Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System

FDA device recall Z-2063-2021 · posted 2021-07-12 · Open, Classified

Recall details

Recalling firm: GE Healthcare, LLC
Reason for recall: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
Action taken: Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss an issue on the affected products listed below where the Patient Orientation button may inadvertently be clicked when intending to click on the Save RX button. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned.
Root cause: Software design
Status: Open, Classified
Product code: LNH
Quantity affected: 1519 units
Distribution: Worldwide distributions.
Date initiated: 2021-06-04
Date posted: 2021-07-12
Location: Waukesha, WI

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Record	Firm	Date
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (K163331)	Ge Medical Systems, LLC	2017-03-17
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (K160618)	Ge Medical Systems, LLC	2016-06-09
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T (K142085)	Ge Medical Systems, LLC	2014-09-26