Recall Z-2054-2021— GE Healthcare, LLC

Name: FDA recall Z-2054-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-04

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2021-06-04. It names 3 FDA 510(k) clearances: K160621, K153003, K143345. Product: SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.. Reason: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-06-04
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

3 on FDA's record

K160621 — SIGNAPioneerGE Healthcare·cleared 2016-03-29
K153003 — SIGNA PioneerGE Healthcare·cleared 2015-10-27
K143345 — SIGNA PioneerGe Healthcare Japan Corporation·cleared 2015-07-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.