—#187994

Product

SIGNA Voyager, Nuclear Magnetic Resonance Imaging System

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K161567, K192426
Affected lot / code info: N/A

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide distributions.

Timeline

Recall initiated: 2021-06-04
Posted by FDA: 2021-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187994. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.