Recall Z-1633-2010
Leica Microsystems, Inc. · initiated March 29, 2010
Product
Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620, M844/820, M525 and M720; There are two wireless models: a) MFS20, stock number 10448406, a 12 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed; b) MFS21, stock number 10448407, a 16 function wireless footswitch type B with cross pedals, XY-actuator 10717602 and screw 10630134 for dust protection enclosed;
Codes / lots: stock number 10448406, serial numbers 60110005, 60110004, 60110003, 60110002, 60110001, 50110001 and 120110001; stock number 10448407, serial numbers 80110003 and 221209001
Reason for recall
The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position.
FDA-determined cause: Other
Action taken
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 microscope that has a BIOM accessory. The accounts were requested to complete the attached Acknowledgement Form, listing the serial numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. A company contact was provided in the letter for questions.
Details
- Recall number
- Z-1633-2010
- Initiated
- March 29, 2010
- Posted by FDA
- May 20, 2010
- Terminated
- February 15, 2011
- Product code
- FSO – Microscope, Surgical, General & Plastic Surgery
- Quantity
- 3 units
- Distribution
- Worldwide distribution -- U.S. (nationwide), Canada, Australia, Europe and Asia
- Recalling firm
- Leica Microsystems, Inc., Bannockburn, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1632-2010 | Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models…The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position. | 03/29/2010Terminated |