Reported Feb 27, 2019 · Terminated
PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification…
Leica Microsystems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leica Microsystems, Inc. · 1700 Leider Ln · Buffalo Grove, IL · 60089-6622
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
142 of 142 codes
190216001060516001280916001061216001091216001301015001270516001180716001180716002190716001141016001211016001241016001261016001030317001060317001011216001020317001130716002100316001230216001041115001021115001270416001130516001160516001240516001220217001100417001131115001071216001100816001300816001231116001121216001100816001130616001081216001131216001140317001310816001160816001130117001060217001230317001280317001050417001170117001190416001070415004050516001090516001170516001020816001040816001111016001131116001150217001211116001090217001
- Serial Numbers
- Amount recalled
- 142 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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