Z-0412-2022Class II

Leica Microsystems M220 F12 Microscope Systems

Name: Z-0412-2022 Leica Microsystems M220 F12 Microscope Systems
Creator: Leica Microsystems, Inc.
Published: 2021-11-03
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2021-11-03 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Leica Microsystems M220 F12 Microscope Systems on 2021-11-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0412-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-03
Posted: 2021-12-22
Terminated: 2024-06-18
Recalling firm: Leica Microsystems, Inc.
Product: Leica Microsystems M220 F12 Microscope Systems
Product code: FSO Microscope, Surgical, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Leica Microsystems is issuing this field safety notice as a corrective action for all Leica M220 F12 Surgical Microscopes that were manufactured since market introduction in January 2009 until March 9th, 2017. Leica Microsystems is initiating a field safety corrective action to provide a retention fixture to be added on all Leica M220 F12 Surgical Microscopes manufactured before March 9th, 2017 to ensure patient safety and customer satisfaction. A Leica Microsystems representative will provide the consignee with a retention fixture as an additional means of securing the M220 Optics Carrier. Prior to each use of the M220 F12, consignees should perform the following mandatory inspection: If the gap between the black adapter and the white housing at the end of the swing arm becomes bigger than 3mm or a free rotation of the optics carrier is possible for more than 360: Immediately stop using the device. If you notice any anomalies with your M220 F12 Microscope System before the additional retention fixture is attached to your instrument, please contact a Leica representative for relevant repair of your instrument. If the mandatory inspection performed prior using your M220 F12 does not result in an observed potential defect, you can continue to use the system pending fixation of the retention fixture. Consignees must acknowledge receipt of this Field Safety Notice with the digital acknowledgment form by either scanning the QR code in your mobile phone or with the following link: https://forms.office.com/r/kZfZnwpxbA As an alternative you can also acknowledge receipt of this Field Safety Notice by completing, signing, dating and returning the attached Acknowledgement Form via an email to the following address: [email protected] This Field Safety Notice must be distributed to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred to. Please maintain awarene
Quantity in commerce: 2,800
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0412-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0412-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-29	2021-12-22

Product code FSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)