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Terminated

Leica ARveo and M530 OH6 microscope systems.

FDA Recall Z-2399-2020 · Posted None

Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeEPT
Date Initiated2020-05-20
Date Terminated2021-05-13
Product QuantityDomestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.

Reason for Recall

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

Firm 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.

Root Cause

Other

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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