Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Mult

FDA device recall Z-1162-06 · posted 2006-06-24 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

Patient Burns-The use of the surgical microscope at high light intensity and short working distances can result in patient burns.

Action taken

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: Maximum Light at Short Distance Can Injure Patient See User Manual', to be placed on the stand near the light intensity controller; a laminated card entitled 'Setting the Illumination Intensity' to be hung on the stand with the enclosed wire tie for in-service training; and a training verification form. The IMRs were instructed to visit each of the end user locations on the enclosed list, installing the stickers, providing the new User Manual and providing the staff that uses the microscope another in-service, stressing the proper use of the illumination system. Upon completion of the in-service, the IMRs will complete the training verification form and have a staff member from the OR sign the form verifying that the warning labels were applied and that the staff was trained, and that the user manual was received. The IMRs will then return the verification form to Leica Microsystems.

Root cause

Other

Status

Terminated

Product code

EPT

Quantity affected

581 systems

Distribution

Nationwide

Date initiated

2005-04-12

Date posted

2006-06-24

Date terminated

2008-05-09

Location

Bannockburn, IL