PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects...
FDA Device Recall #Z-0838-2019 — Class II — September 25, 2017
Recall Summary
| Recall Number | Z-0838-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 25, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Leica Microsystems, Inc. |
| Location | Buffalo Grove, IL |
| Product Type | Devices |
| Quantity | 142 units |
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.
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.
Distribution Pattern
Worldwide
Lot / 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
Other Recalls from Leica Microsystems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0477-2023 | Class II | Leica MICROSYSTEMS M530 OHX, Part Number 104487... | Nov 21, 2022 |
| Z-0476-2023 | Class II | Leica MICROSYSTEMS Provido, Part Numbers 104489... | Nov 21, 2022 |
| Z-0475-2023 | Class II | Leica MICROSYSTEMS Proveo 8, Part Number 104490... | Nov 21, 2022 |
| Z-1849-2022 | Class II | Leica Surgical Operating Microscopes, Arveo, Pa... | Aug 26, 2022 |
| Z-1848-2022 | Class II | Leica Surgical Operating Microscopes, ARveo 8, ... | Aug 26, 2022 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.