FDA Recall Terminated

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.

Recall: Z-0772-2019 · Initiated January 2, 2019

Recall

Recall Number
Z-0772-2019
Event Number
81903
Firm
Leica Microsystems, Inc.
FEI Number
3000210133
Product Code
HRM
Status
Terminated
Root Cause
Process control
Initiated
January 2, 2019
Terminated
April 2, 2021
Address
1700 Leider Ln, Buffalo Grove, IL, 60089-6622

Description

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.

Reason

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

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].

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.

Quantity

15 units