Leica Surgical Microscopes: Photodiode Defect Causes Inaccurate Illumination
Leica Microsystems is recalling 32 surgical operating microscopes due to a photodiode component defect that produces inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.
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: FDA Class II recall with no reported illnesses or injuries. The issue is a functional precision defect affecting illumination accuracy rather than an immediate patient safety hazard, consistent with FDA's moderate-risk classification.
Plain-English summary
Leica Microsystems is recalling Leica Surgical Operating Microscopes (PROvido Part Numbers 10448976 and 10448950, 32 units total) due to an internal component change on the photodiodes in the M530 Optics Carrier.
The defect causes inaccurate adjustment of the illumination limits by the surgical microscope's software when BrightCare Plus with Luxmeter is used. This affects the device's ability to properly control surgical lighting during procedures.
Affected devices have been distributed nationwide in the United States. Leica Microsystems is coordinating the recall of the 32 affected devices. Customers in possession of these microscopes should contact Leica Microsystems for replacement or corrective action.
The recalled product
- Product
- Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 32
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)
- a. 10448976
- Serial Numbers: 120322001
- 300122001
- 170921001
- 301221001
- 40122001
- 140522001
- 151221002
- 301021002
- 81221002
- 100222002
- 40222002
- 220821001
- 300122002
- 110322001
- 50322001
- 180921001
- 260821001
- 90622001
- 120422001
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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- HighSurgical microscope power supply may overheat and cause unexpected shutdown
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- 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 · illumination defect
See all →- High