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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAHistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.2025-04-02
- FDABrand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.012025-01-30
- FDALeica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples2024-09-04
- FDALeica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples2024-09-04
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