Recall Z-0772-2019
Leica Microsystems, Inc. · initiated January 2, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0772-2019
- Initiated
- January 2, 2019
- Terminated
- April 2, 2021
- Product code
- HRM – Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- 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…
- Recalling firm
- Leica Microsystems, Inc., Buffalo Grove, IL