medical Class II Updated 2020-06-24

Leica Microsystems, Inc. recalls Leica ARveo and M530 OH6 microscope systems.

Recalled Product

Leica ARveo and M530 OH6 microscope systems.


Hazard / Issue

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

Issued by

FDA

Affected States: 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
Lot/Code Info: 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.
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