Device Recall Leica Microsystems (Schweiz) AG, 의 리콜

Recall

73557

Class 2

Z-1499-2016

2016-01-11

2016-04-15

Terminated

United States

2017-04-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144457

An electronic component of the leica m525 oh4 and leica m720 oh5 surgical microscopes with 400w illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.

The URGENT MEDICAL DEVICE RECALL letter was sent via USPS mail and email on January 25th 2016 to consignees describing the reason for the recall and the necessary steps to take. These included the following: Continue to use the system according to the User Manual. Both illumination units should be checked prior to beginning any operation case. The Leica M525 OH4 and Leica M720 OH5 provide two redundant illumination units. Independent from the issue explained, the user should be reminded that if they notice a failure in the illumination unit that they are currently using, they should switch to the back-up illumination at the next opportunity during surgery by using the "Change Lamp" page 37 for M525 OH4 and page 40 for M720 OH5 button on the control unit "Main" screen (see Picture 2 below) as described in user manual. Changing lamps will interrupt the illumination for less than 5 seconds. They should contact their Leica Microsystems representative for repair of the defective illumination unit before using the instrument for the next surgery. Note: The user manuals of the Leica M525 OH4 and Leica M720 OH5 state: ¿ Never begin an operation with only one functioning xenon lamp! ¿ Like any other instrument in the operating theater this system may fail. Leica Microsystems therefore recommends that a backup system be kept ready during the operation. The recall further describes transmission of the field notice: The notice must be passed on to all those within their organization who need to be aware of it and to any organization where the affected devices has been sold, rented, leased or otherwise transferred. The end users are requested to confirm receipt of the notice by signing, dating and returning the attached Acknowledgement Form' with the serial number of their instrument back to Leica Microsystems by email to: LMGRA@leica-microsystems.com within 10 working days after receipt of field safety notice.