Leica Surgical Operating Microscopes recalled for illumination adjustment defect
Leica Microsystems recalls 25 Leica Surgical Operating Microscopes (Part Number 10448999) due to a photodiode component change causing inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.
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 3/5 (High).
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: FDA Class II surgical device recall involving a functional defect in illumination control. The defect affects optical precision in a device used during surgery, where proper illumination is critical. This constitutes a risk-of-harm product, meeting the Level 3 threshold.
Plain-English summary
Leica Microsystems is recalling 25 units of Leica Surgical Operating Microscopes, Arveo (Part Number 10448999), distributed nationwide. The company discovered a component change in the photodiodes within the M530 Optics Carrier during internal testing.
The component change causes inaccurate adjustment of illumination limits by the microscope software when BrightCare Plus with Luxmeter is used. This affects the device's ability to properly control light output during surgical procedures.
Facilities using affected serial numbers should contact Leica Microsystems for further instructions. The affected serial numbers are: 210721001, 180721001, 190721001, 121021001, 100821001, 60821001, 90821001, 120821001, 10821001, 80721001, 40821001, 130821001, 290821001, 240821001, 91021001, 180921001, 181121001, 151021001, 190821001, 160921001, 20721001, 50721001, 40921001, 150821001, 160821001.
The recalled product
- Product
- Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 25
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: 210721001
- 180721001
- 190721001
- 121021001
- 100821001
- 60821001
- 90821001
- 120821001
- 10821001
- 80721001
- 40821001
- 130821001
- 290821001
- 240821001
- 91021001
- 180921001
- 181121001
- 151021001
- 190821001
- 160921001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Leica Microsystems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Leica Microsystems, Inc.
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- HighLeica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue
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