GE Healthcare, LLC Recall 88147
Description: SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
GE Healthcare, LLC Recall 88147 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2052-2021 |
| Event ID | 88147 |
| Event Description | SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. |
| Product Type | Devices |
| Distribution | Worldwide distributions. |
| Quantity | 100 devices |
| Recall 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. |
| Device Classification | 20210721 |
| Device Code Info | Not Available |
| Center Classification Date | 20210712 |
| Recall Initiation Date | 20210604 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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