High FDA (Devices)·Z-0772-2019·Announced 2019-01-30

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.

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: 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 treatmen
Manufacturer: Leica Microsystems, Inc.
Category: Medical Device — Surgical Microscope
Hazard: falling-object
patient-contact
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.

Same manufacturer · Leica Microsystems, Inc.

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Same hazard · falling object