Recall Z-2057-2021 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
GE Healthcare, LLC
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
| Date | Jul 12, 2021 (initiated Jun 4, 2021) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | Deployment of the original customer letter to consignees in the U.S. began on June 4, 2021. Dissemination of the updated customer letter to consignees in the U.S. began on June 11, 2021. The letters discuss 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. Users are directed to review and confirm that the actual patient orientation matches the prescribed patient orientation before initiating the scan. A correction is planned. |
| Quantity | 71 devices |
| Distribution | Worldwide distributions. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163619 | SIGNA PET/MR Ge Medical Systems, LLC, Feb 14, 2017 |