| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01052-1 |
| Product Name/Description |
Multiple Models of GE Nuclear Medicine Systems:
All VG and VG Hawkeye nuclear medicine systems, manufactured from 1996 - 2003:
- Millennium VG
- Millennium VG and Hawkeye
- Discovery VH
- Varicam
All Infinia nuclear medicine systems, manufactured from 2003 – 2014:
- Infinia
- Infinia and Hawkeye - Infinia and Hawkeye 4
All Brivo NM615, Discovery NM630, Optima NM/CT640 and Discovery NM/CT670 systems.
ARTG number: 200439 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently performed field actions (TGA Ref.: RC-2013-RN-00629-1; RC-2013-RN-00679-1; RC-2013-RN-00695-1) on GE Healthcare Nuclear Medicine System due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry . As part of this field action, GE Healthcare is updating the Preventative Maintenance procedure and schedule and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicine systems. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising the customers to ensure that the organization that services the equipment uses the latest version of the Service manual and the Preventative Maintenance procedure available on GE website (link provided in the customer letter).
This action has been closed out on the 14/09/2018 |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |