Leica Microsystems, Inc.: 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.

Recall number

Z-0838-2019

Recalling firm

Leica Microsystems, Inc.

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.

Status

Terminated

Initiated

2017-09-25

Posted

not on file

Terminated

2020-01-21

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.

Root cause

Other

Action

The firm initiated their field notification by email on 09/25/2017. The firm provided details on the issues and requested the user to take the following actions: "If you notice any of the anomalies as described above before being contacted by a Leica Microsystems representative, please contact your Leica representative for relevant repair of your PROVEO 8. You can continue to use the system pending the intervention of the appropriate Leica Microsystems representative. However, please ensure that a functional check is performed and the system is properly balanced prior to surgery as required by and described in chapters 17.1 Checklist before operation and 7.7.1 Balancing the parallelogram of the user manual. During surgery, ensure that no functional switches are activated at the same time as a user profile or mode is changed. During the start-up of the system, ensure that no functional switches are activated until the system boots up."

Quantity

142 units

Distribution

Worldwide

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

HRM

Firm FEI

3000210133

Firm city

Buffalo Grove

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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