Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28617 |
| Brand Name: | MRI system, full-body, superconducting magnet |
| Model: | Sagittal VIBRANT with NoSlabWrap factor greater than 1.0. |
| Affected: | |
| Software version: | |
| Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
| Contact Information: | 0800 659 465 |
| Manufacturer: | GE Healthcare Tianjin Company Ltd |
| Issue: | The manufacturer has recently become aware of an issue on the affected products listed below, which impacts breast imaging when running the Sagittal VIBRANT application with ASSET. The issue arises when the NoSlabWrap factor is set to a value larger than the default value of 1.0. In this scenario, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/11/2021 |
