Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23965 |
| Brand Name: | MRI system, full-body, superconducting magnet |
| Model: | Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity/Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO, Signa Ovation with Excite/0.7T Signa OpenSpeed, Signa Ovation HD, Signa HDe, 1.5T Signa HDx |
| Affected: | |
| Software version: | |
| Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
| Contact Information: | 0800 659 465 |
| Manufacturer: | GE Medical Systems LLC |
| Brand Name: | MRI system, full-body, superconducting magnet |
| Model: | Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity/Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO, Signa Ovation with Excite/0.7T Signa OpenSpeed, Signa Ovation HD, Signa HDe, 1.5T Signa HD |
| 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: | It has come to the manufacturer attention that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/12/2018 |
