Leica PROVEO 8 Ophthalmic Microscope System Recalled for Software Defects
Leica Microsystems is recalling 142 PROVEO 8 Ophthalmic Microscope Systems worldwide due to software anomalies that may cause unexpected movement interruptions or delayed function stops.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source describes software anomalies that cause interruptions or delayed stops in a controlled medical environment, without reporting any injuries or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Leica Microsystems, Inc. is recalling 142 units of the PROVEO 8 Ophthalmic Microscope System. These devices are optical instruments used for observation, documentation, and medical treatment in both human and veterinary settings. The recall covers units distributed worldwide.
The recall is due to observed issues that 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 on-screen display functionality of the HDR recording unit. Additionally, a software anomaly may cause the device to not immediately stop an actuated function when a user releases a handle or foot switch button. This specific behavior is noted to occur only in unlikely workflows where a user changes a profile or mode at the same time a functional button is activated.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take, such as stopping use or contacting the manufacturer. Users should refer to the official FDA recall notice for specific remediation steps.
The recalled product
- 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.
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 142
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 190216001
- 060516001
- 280916001
- 061216001
- 091216001
- 301015001
- 270516001
- 180716001
- 180716002
- 190716001
- 141016001
- 211016001
- 241016001
- 261016001
- 030317001
- 060317001
- 011216001
- 020317001
- 130716002
- 100316001
Distribution
Distribution scope not specified by the agency.
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