FDA recall Z-2065-2021

Product

1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System

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.

Distribution

Worldwide distributions.

Key facts

Status

Ongoing

Initiation date

2021-06-04

Report date

2021-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2065-2021