Leica Microsystems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0838-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 25, 2017

Date Posted: February 27, 2019

Recall Number: Z-0838-2019

Event ID: 78190

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.

Status: Terminated

Product Quantity: 142 units

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

Voluntary or Mandated:

Voluntary: Firm initiated