Leica M220 F12 Surgical Microscope Recalled for Falling Optics Hazard
Leica Microsystems is recalling 15 Leica M220 F12 surgical microscopes because the optics may drop into the surgical field, risking contact with the patient.
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: The recall involves a risk-of-harm product where injury has not yet been reported, which corresponds to a High severity score of 3 according to the rubric.
Plain-English summary
Leica Microsystems, Inc. is recalling 15 units of the Leica M220 F12 surgical microscope. The recall is due to a defect where the M220 optics may unintentionally drop into the surgical field, creating a risk of contact with the patient.
The affected units were distributed worldwide, including in the United States and numerous other countries. The recall notice lists specific serial numbers for the 15 units involved.
Healthcare facilities and users should stop using the affected Leica M220 F12 surgical microscopes and contact Leica Microsystems for instructions on how to proceed with the recall.
The recalled product
- Product
- Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical…
- Manufacturer
- Leica Microsystems, Inc.
- Affected units
- 15
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 (15)
- Serial Numbers: 10448367-60618002
- 10448367-150317002
- 10448367-40518001
- 10448367-170417002
- 10448367-80517001
- 10448367-131117001
- 10448367-271117001
- 10448367-91017002
- 10448367-220318003
- 10448367-61017001
- 10448367-171117001
- 10448367-90418001
- 10448367-170417001
- 10448367-20418001
- 10448367-170718002
Distribution
Distributed nationwide across the United States.
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