| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00838-1 |
| Product Name/Description |
Ceiling Supply Units (CSU) 80xx/CSU60xx (Used for positioning of medical gas and vacuum systems)
ARTG Number: 132260 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received reports where the drive screw in the motor unit, which lifts and lowers the lower lift arm broke. As a result, the lift arm fell down approximately 60cm (23.6 inches). If the drive screw breaks, personnel standing under the Ceiling Supply Unit (CSU) may be injured or objects damaged. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Draeger will be performing an inspection of affected devices to identify potential fractures of the drive screw during the next maintenance cycle. If a user does not have a service contract with Draeger, an inspection can be commissioned or alternatively, the end user's technical department can carry out the inspection by following the maintenance instructions provided with the recall letter. |
| Contact Information |
03 9244 7248 - Draeger Medical Australia |