Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown
Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.
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 FDA Class II medical device recall involves potential device malfunction during use. No injuries or deaths have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High severity.
Plain-English summary
Leica Microsystems, Inc. is recalling the Leica MICROSYSTEMS M530 OHX surgical microscope system (Part Number 10448737) due to a power supply overheating issue.
The power supply may become overheated due to internal components overstressing. When this occurs, a specific internal component can fail, causing the device to unexpectedly shutdown during use.
The recall affects 148 units distributed nationwide in the United States. Specific serial numbers are identified in the FDA recall documentation, with additional serial numbers added in an expansion issued on September 8, 2023.
The recalled product
- Product
- Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- power-supply-overheat
- device-failure
- unexpected-shutdown
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: 10622001
- 10622002
- 10822001
- 20322002
- 20522001
- 20622001
- 30122001
- 30322001
- 30522001
- 30622002
- 30722001
- 31221001
- 40422001
- 41221001
- 50122001
- 60122001
- 60522001
- 60622001
- 70122001
- 70322001
Distribution
Distributed nationwide across the United States.
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