Leica ARveo and M530 OH6 microscope systems.
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- May 20, 2020
- Terminated
- May 13, 2021
- Recall Number
- Z-2399-2020
- Quantity
- Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.
- Firm Location
- Buffalo Grove, IL
Reason for Recall
Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
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
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.
Root Cause
Other
Action Taken
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.