Recall Z-2399-2020 ยท EPT Microscope, Surgical
Leica Microsystems, Inc.
Leica ARveo and M530 OH6 microscope systems.
| Date | May 20, 2020 |
| Status | Terminated |
| Reason | Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage. |
| Root cause | Other |
| Action | The firm sent letters to consignees on May 20, 2020 advising them that they can continue to use the system pending this field update. Based on our data analysis, the probability of occurrence for this issue (excessive voltage fluctuation and a subsequent microscope shut off) is remote. However, please ensure that a functional check is performed prior to each surgery as described in section 16.1, directions for the operator of the instrument of the user manual. |
| Quantity | Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77. |
| Distribution | Domestic distribution: AL,AR,AZ, CA, CT, DC, DE, FL, IL, KY, LA, MI, MN, MO, NC, NY, OH. OR. TN, TX, UT, VA, WA, WI ,WV. International distribution: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.