Recall Z-1499-2016 ยท FSO Microscope, Surgical, General & Plastic Surgery
Leica Microsystems, Inc.
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
| Date | Apr 15, 2016 (initiated Jan 11, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 381 units |
| Distribution | Worldwide Distribution-US (nationwide) including Puerto Rico and the states of MA, CA, SC, NJ, TX, CO, FL, PA, NY, MO, WI, NC, UT, ID, AZ, MI, KY, CT, OR, , IL, AL, MN, MT, OH, NE, GA, IN, SD, TN, OK, AK, KS, NV, NM, , ND, VA, WA, WY and MD, and the countries of China, Belgium, France, Germany, Gre |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.