Recall Z-1042-2012 ยท ETP Stimulator, Caloric-Water
Leica Microsystems, Inc.
Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland The intended use of the microscope is for improving the visibility of objects
| Date | Feb 16, 2012 (initiated Dec 21, 2011) |
| Status | Terminated |
| Reason | Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use. |
| Root cause | Device Design |
| Action | The firm, Leica Microsystems, Inc., sent a "Medical Device Correction" notice dated December 21, 2011 to all affected customers by e-mail. The product, problem, and actions to be taken by the customers were addressed. Customers were instructed- DO NOT USE use the affected product until the software could be upgraded and complete and return the Acknowledgement Form via fax to: 1-847-607-3147 or Scan and send to elizabeth.culotta@leica-microsystems.com. Leica Microsystems representatives will contact the customers to make necessary arrangements to complete the software upgrade. If you have any |
| Quantity | 29 units (10 units-USA) |
| Distribution | Worldwide distribution: USA (nationwide) including states of: California, Colorado, Illinois, New York, Oregon, South Carolina; and countries of: Australia, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.