Recall Z-1162-06 ยท EPT Microscope, Surgical
Leica Microsystems, Inc.
Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated field continuously adjustable and high power 300W xenon lamp (both main and back-up illimuniation) through fiber optic cable; Leica Microsystems (Schweiz) AG, Business Unit SOM, Max Schmidheiny-Strasse
| Date | Jun 24, 2006 (initiated Apr 12, 2005) |
| Status | Terminated |
| Reason | Patient Burns-The use of the surgical microscope at high light intensity and short working distances can result in patient burns. |
| Root cause | Other |
| Action | Leica Microsystems faxed a memo entitled 'M520 Heat Issues' to all IMRs on 11/15/05, informing them that the potential to burn exposed patient skin at the closer working distances with the high intensity of light exists with the M520 optics carrier and/or new optichrome light source. The IMRs were sent retrofit packets which consisted of a current User Manual with 'Caution: The light source in this unit may be too bright at shorter focal lengths for surgeon and patient. Please start with light low and turn up till the surgeon has an excellent optical image.'; a sticker reading 'Warning: Maxi |
| Quantity | 581 systems |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.