| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00976-1 |
| Product Name/Description |
Stryker Standard Video Cart and Vision Mounting Arm
Catalogue Numbers: 0240099011 (Video Cart), 0240099011I (Video Cart), 0240095200 (Mounting Arm)
All lots affected
ARTG Number: 106511 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
If the tension screw present in the mounting yoke of the Vision Mounting Arm is loose and the user applies excessive force during positioning, the user can push the monitor out of the yoke. This will cause the monitor to dislodge from the mounting arm and fall potentially impacting an operator or patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker is advising users that a new screw and washer will be installed on all affected units to ensure the monitor is securely fastened to the mounting yoke. It is expected that this will be completed by April 2014. |
| Contact Information |
1800 803 601 - Stryker Australia |