Leica ARveo and M530 OH6 microscope systems — Class II medical device recall Z-2399-2020
Terminated recall by Leica Microsystems, Inc., reported 2020-06-24, distributed in AL, AR, AZ, CA, CT, DC, DE, FL…. Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in volta
| Recall number | Z-2399-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2020-05-20 |
| Classified | 2020-06-17 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2021-05-13 |
| Distributed | 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 |
| Countries outside the US | JP |
| Model numbers | 10448680, 10448999, OH6-009815, OH6-016215, OH6-030016, OH6-032016, OH6-042317, OH6-044518, OHA-000318, OHA-000418, OHA-000618, OHA-000718, OHA-000818, OHA-001018, OHA-001118, OHA-001218, OHA-002218, OHA-002618, OHA-003718, OHA-004818, OHA-005418, OHA-006318, OHA-007618, OHA-007818, OHA-008518 and 42 more |
Product
Leica ARveo and M530 OH6 microscope systems.
Reason for recall
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2399-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.