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.
FDA Recall Z-0772-2019 · Posted None
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Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeHRM
Date Initiated2019-01-02
Date Terminated2021-04-02
Product Quantity15 units
Reason for Recall
The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
Firm 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: [email protected].
Root Cause
Process control
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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