Recall Z-0772-2019 ยท HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Leica Microsystems, Inc.
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.
| Date | Jan 2, 2019 |
| Status | Terminated |
| Reason | The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. |
| Root cause | 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 | 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, R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.