FDAClass IIJanuary 30, 2019

Leica M220 F12 surgical microscope The Leica M220 F12 recall

Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through…

Why was Leica M220 F12 surgical microscope The Leica M220 F12 recalled?

The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through…
Recalling firm
Leica Microsystems, Inc.
Quantity
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.
Recall date
January 30, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls