Recall Z-0477-2023 ยท EPT Microscope, Surgical
Leica Microsystems, Inc.
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
| Date | Dec 9, 2022 (initiated Nov 21, 2022) |
| Status | Open, Classified |
| Reason | There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown. |
| Root cause | Process control |
| Action | The firm issued an URGENT FIELD SAFETY NOTICE to its consignees by email on 11/21/2022. The notice explained the issue and stated that a Leica Microsystems representative would be contacting each facility to arrange an update to the the affected devices and advised the following: Consignees can continue to use the system pending the field update; Ensure that all users of the affected microscope are aware of the Safety notes as described in section 3 of the respective user manual; Like any other instrument in the operating theater, the system may fail and Leica Microsystem (Schweiz) AG recomm |
| Quantity | 148 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.