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U.S. Department of Health and Human Services

Class 2 Device Recall Leica M220 F12 surgical microscope

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  Class 2 Device Recall Leica M220 F12 surgical microscope see related information
Date Initiated by Firm January 02, 2019
Create Date January 24, 2019
Recall Status1 Terminated 3 on April 02, 2021
Recall Number Z-0772-2019
Recall Event ID 81903
Product Classification Microscope, operating & accessories, ac-powered, ophthalmic - Product Code HRM
Product 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.
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 
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		 The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
FDA Determined
Cause 2		 Process control
Action The firm, Leica, disseminated an "URGENT FIELD SAFETY NOTICE" dated 12/18/2018 on 01/02/2019 to its customers. The notice described the product, problem and actions to be taken. The notice directed the user to inspect the device for a gap between the black adapter and the white housing or a free rotation of the optics carrier for more 360o. If either are noted, the device could not be used. If you have any questions, contact the Clinical & Scientific Affairs Specialist at 847-876-5705 or email to: Jason.Battle@leica-miosystems.com.
Quantity in Commerce 15 units
Distribution 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.
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.
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