Leica M530 Surgical Microscopes recalled for illumination adjustment defect
Leica Microsystems is recalling 115 M530 surgical microscopes due to a photodiode component change that causes inaccurate illumination limit adjustment when using the BrightCare Plus feature with Luxmeter.
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: This is an FDA Class II recall of surgical operating microscopes with a component defect that impairs illumination control accuracy. No injuries or deaths have been reported; however, the defect presents a potential risk during surgical use where precise illumination is critical.
Plain-English summary
Leica Microsystems is recalling 115 Leica Surgical Operating Microscopes, Model M530 OHX (Part Number 10448737), distributed nationwide in the United States. The recall was initiated following Leica's internal testing, which identified a problem with affected units.
The microscopes contain a photodiode component change in the M530 Optics Carrier. This component change causes the software to inaccurately adjust the illumination limits when the BrightCare Plus feature with Luxmeter is used. The illumination control becomes unreliable in affected devices.
Hospitals, surgical centers, and other healthcare facilities with these microscopes should verify their equipment serial numbers against the FDA recall list and contact Leica Microsystems for remediation instructions. This is an FDA Class II recall.
The recalled product
- Product
- Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 115
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: 270422001
- 160322001
- 230222001
- 140422001
- 100122002
- 60721001
- 290522001
- 310522001
- 81121001
- 290921001
- 130122001
- 111021001
- 131021001
- 171021001
- 10622002
- 280222002
- 51121001
- 90821001
- 170222001
- 170522001
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
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