| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00935-1 |
| Product Name/Description |
Leica Ceiling Mounts MSF-1, MS-1F and MC-1F (Used for mounting surgical microscopes)
Leica Ceiling Mount MSF-1
Art. Numbers: 10446781 & 10446782
Leica Ceiling Mount MS-1F & MC-1F
Art. Numbers: 10446657 & 10446658
ARTG Number: 137683 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Leica Microsystems is notifying their customers of an important safety issue concerning the Ceiling Supply Units CSU 80xx/ CSU 60xx, manufactured from 1997 - 2003. The ceiling mount supplier encountered an event in which 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 60 cm (23.6 inches). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Leica Microsystems is contacting their customers to arrange for the complete inspection of the ceiling mount and is providing customers with additional preventative maintenance protocols. |
| Contact Information |
02 8870 3500 - Leica Microsystems Regulatory Affairs |