| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00652-1 |
| Product Name/Description |
M320 Microscope Systems
Article/Catalogue Numbers: 10448419, 10448420, 10448485 and 10448486
Manufactured between 18 May 2014 and 21 January 2015.
ARTG: 137683
(LEICA MICROSYSTEMS - Microscope, surgical) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Internationally, three complaints were reported involving mechanical part failures for the Leica M320 Microscope System. These specific systems had failures with the screws that hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. This may potentially cause the M320 optics carrier to drop to the lower mechanical end stop.
This failure was identical in all three complaints and has been linked to an identified batch of screws, used in the manufacture of the gas spring fixation bracket. These screws have been determined to be non-conforming.
In the event that this observed defect were to occur, the M320 optics carrier may unintentionally drop into the surgical field, risking contact with the patient. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Leica is advising they will contact affected users to arrange replacement of the mechanical parts of the parallelogram for all M320 microscopes manufactured with screws from the nonconforming batch.
This action has been closed out on 09/07/2019 |
| Contact Information |
1800 625 286 - Leica Microsystems |