Z-2399-2020 Class II Terminated
FDA device recall Z-2399-2020 was initiated by Leica Microsystems, Inc. on May 20, 2020 and is designated Class II. Reason for recall: Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage. The recall status is terminated (terminated May 13, 2021). Affected quantity: Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77..
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2020
- Initiation Date
- May 20, 2020
- Termination Date
- May 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.
Product Description
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.
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
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.