Class 2 Device Recall Leica M220 F12

• Date Initiated by Firm: November 03, 2021
• Create Date: December 22, 2021
• Recall Status: Terminated on June 18, 2024
• Recall Number: Z-0412-2022
• Recall Event ID: 89009
• Product Classification: Microscope, surgical, general & plastic surgery - Product Code FSO
• Product: Leica Microsystems M220 F12 Microscope Systems
• 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
• FEI Number: 3000210133
• Recalling Firm/ Manufacturer: Leica Microsystems, Inc.; 1700 Leider Ln; Buffalo Grove IL 60089-6622
• For Additional Information Contact: Philip De Guia; 847-291-1125 Ext. 7120
• Manufacturer 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.
• FDA Determined 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: LMG-RA-Mailbox@leica-microsystems.com 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.