PROVEO 8 Ophthalmic Microscope System optical instrument for… — Class II medical device recall Z-0838-2019
Terminated recall by Leica Microsystems, Inc., reported 2019-02-27. The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermitt
| Recall number | Z-0838-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Microsystems, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2017-09-25 |
| Classified | 2019-02-15 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2020-01-21 |
| Quantity | 142 units |
| Reason classes | software |
| Serial numbers | 010316001, 010317001, 010916001, 011116001, 011216001, 020217001, 020317001, 020416001, 020616001, 020816001, 021115001, 030317001, 030616001, 031216001, 040516001, 040816001, 041115001, 041216001, 050117001, 050417001, 050516001, 050916001, 060217001, 060317001, 060416001 and 113 more |
Product
PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Reason for recall
The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper on-screen display functionality of the HDR recording unit. Additionally, an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0838-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.