Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Reported: October 5, 2022 Initiated: August 26, 2022 #Z-1848-2022
Product Description
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Reason for Recall
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
Details
- Recalling Firm
- Leica Microsystems, Inc.
- Units Affected
- 30 devices
- Distribution
- US Nationwide distribution.
- Location
- deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063. Recalled by Leica Microsystems, Inc.. Units affected: 30 devices.
Why was this product recalled? ▼
During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-1848-2022.
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