| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00771-1 |
| Product Name/Description |
Leica M525 F40 Surgical Microscopes
Material Number: 10448096
Serial Numbers: 010708001, 010906002, 060505002, 080508001, 100105001, 100608002, 110608001, 180205002, 180410001, 230507001, 231209001, 240609001, 260609001, 290508001, 301106002
ARTG Number: 137683 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Leica Microsystems has identified that the Instructions for Use (IFU) and warnings are not always followed by users of the Leica M525 F40 Surgical Microscopes, in particular for transportation and positioning in the Operating Room (OR). Due to this, additional waning stickers have been introduced for the Leica M525 F40, in addition to a quick reference guide for transporting and position in the OR which can be attached to the instrument.
Using the M525 F40 improperly during transport and positioning can have an adverse effect on the stability of the device. In extreme cases, improper use during transport and positioning can cause tilting of the device. Leica Microsystems has received two reports where a M525 F40 started tilting due to improper handling. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Leica Microsystems is sending warning stickers and “quick reference guides for transport and positioning in the OR”.
2. Users are to arrange the fixation of the warning stickers on the instruments, inform or personnel accordingly and fill out the supplied acknowledge form.
This action has been closed out on 03/04/2020 |
| Contact Information |
03 9211 7400 - Leica Biosystems |