| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01256-1 |
| Product Name/Description |
Leica M525 F50 Surgical Microscope with XY-Unit (surgical light microscope)
Material Number: 10448505
Serial numbers: 260213001, 70613002, 80911001, 110613001, 180712001, 30913001
Manufactured from 10 May 2010 to 18 November 2013
ARTG Number: 137683
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Leica Microsystems has identified that in certain activations of the XY, the system can continue to run laterally to its limit (run-on), but will stop if the surgeon activates any button. Run-on of the XY can only occur in the rare situation of rapid consecutive activation on the 45 degrees, 135 degrees, 225 degrees or 315 degrees. In addition, the run-on will stop if any other activation of the XY occurs. The XY run-on is disruptive as the adjustment to the field of view could take up to 24 seconds longer than usual, however there is a low risk to patients. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Leica is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent fix. |
| Contact Information |
02 8870 3500 - Leica Microsystems |