| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00643-1 |
| Product Name/Description |
OEC Elite systems
Distributed between 27 October 2016 and 28 March 2017
ARTG Number: 132698 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare Surgery recently identified that product use labels on certain OEC Elite systems were missing or applied in the incorrect location on the device. The missing labels have the potential to result in users overlooking safe operating practices and exposing themselves or others to potential hazards that may lead to significant harm. To date, there have been no injuries reported because of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised they may continue to use the OEC Elite system and to consult the Operator Manual regarding safe use of the system and precautions to be taken:
- before initial use of the device
- when transporting or moving the system
- when connecting, or disconnecting external equipment/accessories
- when locking, and unlocking brakes using the brake handle or pedal
- when checking/contacting electrical connectors
GE Healthcare will contact users to arrange for product correction.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 659 465 - GE National Call Centre |