Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00406-1 |
Product Name/Description |
Monitor AC2000 Spring Arm
Part Numbers: G19051 and G19262 All serial numbers affected
Part Number: G93358 All serial numbers until 0111 066 23639 affected
Part Number: G93359 All serial numbers until 0111 056 21343 affected
ARTG Number: 132260 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
7/04/2014 |
Responsible Entity |
|
Reason/Issue |
Draeger Medical Australia has been informed of three cases where a welded seam in the spring-loaded arm of the monitor holder broke resulting in the monitor falling. Although no injury has been reported, the risk of injury to persons positioned beneath the monitor cannot be excluded. |
Recall Action |
Recall |
Recall Action Instructions |
A Drager service representative will inspect all potentially affected spring-loaded arms. A replacement arm will be provided for all devices determined to be affected. |
Contact Information |
1800 800 327 - Draeger Medical Australia Pty Ltd |