Leica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue
Leica Microsystems is recalling 30 ARveo 8 surgical microscopes (Part Number 10449063) distributed nationwide due to a photodiode component change causing inaccurate illumination adjustment when using the BrightCare Plus Luxmeter feature.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device where a component malfunction can cause inaccurate illumination adjustment during procedures. While no illnesses or injuries have been reported, the device functionality issue represents a risk-of-harm product category as defined in the severity rubric.
Plain-English summary
Leica Microsystems is recalling 30 Leica Surgical Operating Microscopes, model ARveo 8 (Part Number 10449063), which were distributed nationwide in the United States.
A component change in the photodiodes inside the M530 Optics Carrier causes inaccurate adjustment of the illumination limits by the surgical microscope's software when the BrightCare Plus feature with Luxmeter is used. This issue was discovered during internal testing at Leica Microsystems.
Affected devices can be identified by their serial numbers. Healthcare facilities and users who have these microscopes should verify their device's serial number and contact Leica Microsystems for remediation instructions or replacement.
The recalled product
- Product
- Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- illumination-accuracy
- equipment-malfunction
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: 30622001
- 41221001
- 100522001
- 50322001
- 60522001
- 11221001
- 301121001
- 20622001
- 191121001
- 91221001
- 61221001
- 81221001
- 281121001
- 291121001
- 181121001
- 300522001
- 71221001
- 20322001
- 30322001
- 60322001
Distribution
Distributed nationwide across the United States.
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