Home / Recalls / Leica Microsystems, Inc. / Z-0412-2022

Z-0412-2022 Class II Terminated

Recalled by Leica Microsystems, Inc. — Buffalo Grove, IL

FDA device recall Z-0412-2022 was initiated by Leica Microsystems, Inc. on November 3, 2021 and is designated Class II. Reason for recall: 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 defec… The recall status is terminated (terminated June 18, 2024). Affected quantity: 2,800.

Recall Details

Product Type
Devices
Report Date
December 29, 2021
Initiation Date
November 3, 2021
Termination Date
June 18, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,800

Product Description

Leica Microsystems M220 F12 Microscope Systems

Reason for Recall

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.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of CA, DC, FL, GA, IL, IN, MA, MI, MD, NY, OH, OR, PA, TN, TX, VA, WI, and Puerto Rico. The countries of Albania, Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Canada, Chile, China, Colombia, Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Georgia, Great Britain, Greece, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, South Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, North Macedonia, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Uruguay, Vietnam.

Code Information

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

Other recalls by Leica Microsystems, Inc.

  • Z-0475-2023 Class II — Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system (November 21, 2022)
  • Z-0476-2023 Class II — Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard) (November 21, 2022)
  • Z-0477-2023 Class II — Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system (November 21, 2022)
  • Z-1850-2022 Class II — Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 (August 26, 2022)
  • Z-1851-2022 Class II — Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 104 (August 26, 2022)
  • Z-1849-2022 Class II — Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 (August 26, 2022)
  • Z-1848-2022 Class II — Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 (August 26, 2022)
  • Z-2481-2021 Class II — BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 (July 30, 2021)
  • Z-2399-2020 Class II — Leica ARveo and M530 OH6 microscope systems. (May 20, 2020)
  • Z-0673-2020 Class II — BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is (November 18, 2019)

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