Reported Dec 29, 2021 · Terminated

Leica Microsystems M220 F12 Microscope Systems

Leica Microsystems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Leica Microsystems, Inc. · 1700 Leider Ln · Buffalo Grove, IL · 60089-6622

Is this the product you have?

  • Leica Microsystems M220 F12 Microscope Systems
Lot codes and dates
  • Part #: 10448367 UDI #: 07630003552188 U.S. Serial #'s: 180709002, 191109001, 261016002, 250815001, 280813001, 251111006, 61209001, 260810003, 240815001, 171116001, 190815001, 151209004, 261016001, 70715001, 60713002, 140510004, 180712001, 300910003, 161013001, 270612001, 140510005, 250512002, 10712002, 130913001, 51112001, 290414001, 260311001, 180515001, 270813001, 231014001, 110614001, 210814001, 180515002, 111212001, 270812001, 100614001, 171214002, 290514003, 101212001, 291013001, 50614002, 81012001, 30514001, 101212002, 40611002, 50614003, 171116002, 200314001, 170212001, 30311002, 150211001, 130913002, 60210005, 100212001, 290509001, 111113001, 120615003, 100212002, 300411006, 110315001, 210612002, 100212003, 210612001, 30614001, 20816001, 100212004, 260816001, 260816002, 291113001, 100212005, 21109002, 260811001, 100810004, 90112002 Canada Serial #'s: 260311010, 240414001, 70414002
Amount recalled
2,800

Where it was sold

Why it was recalled

In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 18, 2024 · Data as of Sep 19, 7:34 PM UTC

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