Recall Z-0412-2022 ยท FSO Microscope, Surgical, General & Plastic Surgery
Leica Microsystems, Inc.
Leica Microsystems M220 F12 Microscope Systems
| Date | Nov 3, 2021 |
| Status | Terminated |
| Reason | 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 | 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. |
| Quantity | 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.