GE Healthcare, LLC Recall 87023
Description: GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
GE Healthcare, LLC Recall 87023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0855-2021 |
| Event ID | 87023 |
| Event Description | GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. |
| Product Type | Devices |
| Distribution | Worldwide |
| Quantity | 12 units |
| Recall Reason | GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector. |
| Device Classification | 20210120 |
| Device Code Info | Serial numbers: 87CY63028, 87CZ63044, 87CZ63045, 87CZ63042, 87CY63025, 87CY63029, 87CY63027, 87CY63030, 87CZ63046, 87CY63034, 87CY63032, 87CY63033 |
| Center Classification Date | 20210113 |
| Recall Initiation Date | 20201210 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
| Similar To |