FDA Medical Device Recalls (openFDA)
Leica Microsystems, Inc.: Leica ARveo and M530 OH6 microscope systems.
- Recall number
- Z-2399-2020
- Recalling firm
- Leica Microsystems, Inc.
- Product
- Leica ARveo and M530 OH6 microscope systems.
- Status
- Terminated
- Initiated
- 2020-05-20
- Posted
- not on file
- Terminated
- 2021-05-13
- Reason
- Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
- 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
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EPT
- Firm FEI
- 1423337
- Firm city
- Buffalo Grove
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28