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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
Related recalls
Same manufacturer · Leica Microsystems, Inc.
See all →- HighSurgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown
FDA (Devices) · 2022-12-21
- HighSurgical microscope power supply may overheat and cause unexpected shutdown
FDA (Devices) · 2022-12-21
- HighLeica Provido surgical microscope models at risk of unexpected power shutdown
FDA (Devices) · 2022-12-21
- HighLeica Surgical Operating Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
- HighLeica M530 Surgical Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 760 CT System Recalled for Software Visibility Issue
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighSurgical microscope power supply may overheat and cause unexpected shutdown
FDA (Devices) · 2022-12-21
- HighLeica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue
FDA (Devices) · 2022-10-05
- HighLeica M220 F12 Surgical Microscope Recalled for Falling Optics Hazard
FDA (Devices) · 2019-01-30
- HighLeica Surgical Microscope Recall Due to Axis Brake Failure
FDA (Devices) · 2013-09-18
- HighLeica Surgical Microscope Recall Due to Brake Failure During Installation
FDA (Devices) · 2013-09-18
- ModerateLeica Surgical Microscopes: Photodiode Defect Causes Inaccurate Illumination
FDA (Devices) · 2022-10-05