Recall Z-1632-2010 ยท FSO Microscope, Surgical, General & Plastic Surgery
Leica Microsystems, Inc.
Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are three cable connection footswitch models : a) MFS11, stock number 10445599, a 6 function footswitch type B with cross pedals; b) MFS12, stock number 10445600, a 12 function footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection en
| Date | May 20, 2010 (initiated Mar 29, 2010) |
| Status | Terminated |
| Reason | The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position. |
| Root cause | Other |
| Action | Leica Microsystems sent Medical Device Correction letters dated 3/29/10 to the affected customers via first class mail on the same date, informing them of the potential for injury to the patient's eye if the cross pedal of the footswitch sticks. They were informed that their local Leica Microsystems representative will contact them to arrange for the replacement of the cross pedal. The letters also provided the interim necessary steps required to avoid the risk of patient injury while they are awaiting the cross pedal replacement, i.e. do not use the affected footswitches with a surgical micro |
| Quantity | 54 units (52 - U.S., 2 - Canada) |
| Distribution | Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.