Surgical microscope power supply may overheat and cause unexpected shutdown
Leica Microsystems is recalling 43 Proveo 8 surgical microscopes nationwide due to a potential power supply defect that may cause device overheating and unexpected shutdown during use.
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 medical device recall involving a surgical microscope that could fail unexpectedly during use. No injuries or illnesses have been reported. The score reflects the risk of harm from an unexpected device shutdown in a surgical setting without documented harm to date, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Leica Microsystems, Inc. is recalling the Leica MICROSYSTEMS Proveo 8 surgical microscope system (Part Number 10449058). The recall involves 43 units distributed nationwide in the United States and was issued due to a potential defect in the power supply system.
The power supply in affected units may overheat due to internal component overstressing. This overstressing can cause a critical internal component to fail, resulting in the device unexpectedly shutting down without warning during operation.
Affected customers should verify the serial number of their device against the FDA recall notice to determine if their unit is included. The recall has been expanded since its initial issuance to include additional affected serial numbers.
The recalled product
- Product
- Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
- Manufacturer
- Leica Microsystems, Inc.
- Hazard
- power-supply-failure
- overheating
- 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: 20522001
- 20722001
- 21221001
- 40222001
- 40722001
- 70722001
- 80522002
- 110722001
- 150422001
- 180322001
- 211021001
- 260722001
- 290422001
- 300122001
- 270522001. ***EXPANSION 09/08/2023
- Serial Numbers: 271222001
- 100423002
- 31022001
- 180623001
- 71222001
Distribution
Distributed nationwide across the United States.
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