GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-2060-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

SIGNA MR380, Nuclear Magnetic Resonance Imaging System

Product Classification:

Class II

Date Initiated: June 4, 2021

Date Posted: July 21, 2021

Recall Number: Z-2060-2021

Event ID: 88147

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.

Status: Ongoing

Product Quantity:

Code Information:

Distribution Pattern:

Worldwide distributions.

Voluntary or Mandated:

Voluntary: Firm initiated