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Z-0772-2019 Class II Terminated

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

FDA device recall Z-0772-2019 was initiated by Leica Microsystems, Inc. on January 2, 2019 and is designated Class II. Reason for recall: The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. The recall status is terminated (terminated April 2, 2021). Affected quantity: 15 units.

Recall Details

Product Type
Devices
Report Date
January 30, 2019
Initiation Date
January 2, 2019
Termination Date
April 2, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 units

Product Description

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 treatment.

Reason for Recall

The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.

Distribution Pattern

Worldwide distribution: US (nationwide) and countries of: Albania, Algeria, Armenia, Argentina, Bangladesh, Brazil, Burundi, Canada, China, Colombia, Egypt, France, Germany, Guatemala, India, Indonesia, Japan, Nepal, Netherlands, New Zealand, Malaysia, Pakistan, Peru, Philippines, Poland, Qatar, Romania, Russia Federation, Saudi Arabia, Senegal, Spain, South Africa, South Korea, Switzerland, Tanzania, Thailand, Turkey, Ukraine, and Vietnam.

Code Information

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

Other recalls by Leica Microsystems, Inc.

  • 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-0475-2023 Class II — Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system (November 21, 2022)
  • Z-1851-2022 Class II — Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 104 (August 26, 2022)
  • Z-1850-2022 Class II — Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 (August 26, 2022)
  • Z-1848-2022 Class II — Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 (August 26, 2022)
  • Z-1849-2022 Class II — Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 (August 26, 2022)
  • Z-0412-2022 Class II — Leica Microsystems M220 F12 Microscope Systems (November 3, 2021)
  • 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)

FDA data resources