FDA Device recall Z-2063-2021
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
- FDA Device
- Class II
- ongoing
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System by Ge Healthcare, citing 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 cli….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2063-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-04 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
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.
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2063-2021%22
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