Leica Microsystems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2399-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Leica ARveo and M530 OH6 microscope systems.

Product Classification:

Class II

Date Initiated: May 20, 2020

Date Posted: June 24, 2020

Recall Number: Z-2399-2020

Event ID: 85722

Reason for Recall:

Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.

Status: Terminated

Product Quantity: Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated