{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190260", "product_res_number": "Z-0412-2022", "event_date_initiated": "2021-11-03", "event_date_created": "2021-12-22", "recall_status": "Terminated", "event_date_terminated": "2024-06-18", "res_event_number": "89009", "product_code": "FSO", "product_description": "Leica Microsystems M220 F12 Microscope Systems", "code_info": "Part #: 10448367\n\nUDI #: 07630003552188 \n\nU.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\n\nCanada Serial #'s: 260311010, 240414001, 70414002", "firm_fei_number": "3000210133", "recalling_firm": "Leica Microsystems, Inc.", "address_1": "1700 Leider Ln", "city": "Buffalo Grove", "state": "IL", "postal_code": "60089-6622", "additional_info_contact": "Philip De Guia\n847-291-1125 Ext. 7120", "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_description": "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. \n\nLeica 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.\nA Leica Microsystems representative will provide the consignee with a retention fixture as an additional means of securing the M220 Optics Carrier.\n\nPrior to each use of the M220 F12, consignees should perform the following mandatory inspection:\nIf 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.\n\nIf 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.\n\nIf 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.\n\nConsignees 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\n\nAs 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\n\nThis 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.\n\nPlease maintain awarene", "product_quantity": "2,800", "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.", "openfda": { "k_number": [ "K822181", "K822562", "K942304", "K920689", "K910357", "K822015", "K931303", "K941399", "K801314", "K926288", "K791280", "K874241", "K902076", "K926513", "K802713" ], "registration_number": [ "3013403214", "3005527296", "", "3009560832", "3029755582", "3032734659", "3031700059", "3014059828", "3006543022", "3014683120", "3013351723", "3005273623", "3030390145", "3007123908", "3010242141", "9610612", "3005755367", "3005527904", "3003974370", "3014388471", "3044710739", "1836161", "3002821232", "1645452", "3025436467", "2127132", "3015180671", "3008590661", "3009598746", "3003591740", "3042172882", "9615010", "3010202439", "3006252153", "2916714", "3013154160", "8010573", "3009340886", "3014644251", "3001644167", "1054713", "1000204638", "1528142", "3003851947", "2020550", "1820334", "8030607" ], "fei_number": [ "3013403214", "3005527296", "", "3009560832", "1000114111", "3029755582", "3032734659", "3031700059", "3014059828", "3006543022", "1000139591", "3002750084", "3014683120", "3013351723", "3005273623", "3030390145", "3007123908", "3007475226", "3010242141", "3006509795", "3005527904", "3005755367", "3003481798", "3003974370", "3014388471", "3044710739", "3002821232", "1000122772", "3025436467", "2127132", "3015180671", "3008590661", "3009598746", "3003591740", "3042172882", "3002806315", "3003169291", "3006252153", "2916714", "3013154160", "3009340886", "3014644251", "3001644167", "1000204638", "3003851947", "2020550", "1820334" ], "device_name": "Microscope, Surgical, General & Plastic Surgery", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4700", "device_class": "1" } } ] }