Device 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.
Z-0838-2019
Product summary
- Event
- Event 78190
- Status
- Terminated
- Classification
- Class II
- Quantity
- 142 units
- Official record key
device-enforcement:Z-0838-2019
Official wording
Reason: 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.
Code information: Serial Numbers: 190216001; 060516001; 280916001; 061216001; 091216001; 301015001; 270516001; 180716001; 180716002; 190716001; 141016001; 211016001; 241016001; 261016001; 030317001; 060317001; 011216001; 020317001; 130716002; 100316001; 230216001; 041115001; 021115001; 270416001; 130516001; 160516001; 240516001; 220217001; 100417001; 131115001; 071216001; 100816001; 300816001; 231116001; 121216001; 100816001; 130616001; 081216001; 131216001; 140317001; 310816001; 160816001; 130117001; 060217001; 230317001; 280317001; 050417001; 170117001; 190416001; 070415004; 050516001; 090516001; 170516001; 020816001; 040816001; 111016001; 131116001; 150217001; 211116001; 090217001; 081116001; 020616001; 050117001; 031216001; 020416001; 010317001; 280416001; 271216001; 251115001; 250316001; 231216001; 230916001; 230217001; 260416001; 030616001; 080616001; 080316001; 250116001; 181016001; 220316001; 130716002; 201116001; 200217001; 180416001; 201216001; 170117002; 150116001; 121115001; 110316001; 060616001; 270217001; 090317001; 160317001; 190217001; 140716002; 101016001; 161115001; 190116001; 130116001; 010316001; 020217001; 121016001; 141016001; 161216001; 171216001; 180116001; 260516001; 300516001; 200716001; 260716001; 191116001; 171116001; 251116001; 131216001; 220416001; 281016001; 011116001; 270116001; 060416001; 231115001; 301015003; 301015002; 280116001; 150216001; 180216001; 290416001; 040516001; 190516001; 230516001; 250516001; 280616001; 300616001; 200616001; 230616001; 140716001; 130716001; 010916001; 050916001; 100117001; 260116001; 101116001; 041216001
Distribution pattern: Worldwide
Derived failure modes
-
Device software or design
anomaly in the device software