Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14856 |
| Brand Name: | GE Infinia Nuclear Medicine Systems |
| Model: | All Infinia systems manfactured from 2003 to 2013; all VG and VG Hawkeye systems manufactured from 1996 to 2003; all Helix systems manfactured from 1992 to 1996 |
| 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 Functional Imaging Haifa |
| Issue: | Following an incident at a medical centre in the United States a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 system. The cause of the incident is under investigation. Users are recommended to ensure; 1/ Only qualified service personnel maintain the equipment 2/ That Preventative Maintenance procedures are conducted according to the documented schedule 3/ All users re-review the safety chapter sections of the system manual |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/6/2013 |
