Z-2399-2020Class II

Leica ARveo and M530 OH6 microscope systems

Name: Z-2399-2020 Leica ARveo and M530 OH6 microscope systems
Creator: Leica Microsystems, Inc.
Published: 2020-05-20
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2020-05-20 / Terminated

FDA source

Leica Microsystems, Inc. began a recall of Leica ARveo and M530 OH6 microscope systems on 2020-05-20. FDA classified it as Class II and gives the reason as "Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2399-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-20
Posted: 2020-06-17
Terminated: 2021-05-13
Recalling firm: Leica Microsystems, Inc.
Product: Leica ARveo and M530 OH6 microscope systems.
Product code: EPT Microscope, Surgical
Reason for recall: Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
FDA 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 in commerce: 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
Product codes and lots: M530 OH6 Serial Numbers for Model # 10448680 OH6-016215, OH6-042317, OH6-032016, OH6-009815,OH6-044518 and OH6-030016. Arveo Serial Numbers for Model # 10448999 OHA-006318, OHA-010719, OHA-011919, OHA-000818, OHA-009119, OHA-000718, OHA-014919, OHA-016619, OHA-015919, OHA-007818, OHA-013519, OHA-001218, OHA-012219, OHA-017319, OHA-000418, OHA-017119, OHA-013719, OHA-009919, OHA-017219, OHA-017419, OHA-002218, OHA-000318, OHA-014819, OHA-015219, OHA-003718, OHA-001018, OHA-016019, OHA-012919, OHA-012619, OHA-011719, OHA-012119, OHA-010819, OHA-016119, OHA-009219, OHA-002618, OHA-015719, OHA-012019, OHA-009519, OHA-000618, OHA-008518, OHA-004818, OHA-012719, OHA-010619, OHA-001118, OHA-010419, OHA-016319, OHA-016519, OHA-010219, OHA-012519, OHA-015419, OHA-009018, OHA-016419, OHA-016719, OHA-008918, OHA-007618, OHA-009619, OHA-012319, OHA-010519, OHA-005418.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2399-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2399-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-17

Product code EPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)