Recall Z-0105-2012 ยท EPT Microscope, Surgical
Carl Zeiss Meditec, Inc.
OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.
| Date | Oct 24, 2011 (initiated Sep 26, 2011) |
| Status | Terminated |
| Reason | An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US locations. |
| Root cause | Nonconforming Material/Component |
| Action | Carl Zeiss Meditec had Field Service Engineers directly contact all affected customers. The Field Service Engineers will replace the defective component. Questions regarding this Field Corrective Action should be directed to the Director of Clinical/Regulatory Affairs at 925-557-4616. |
| Quantity | 3 |
| Distribution | USA (nationwide) including the states of FL, GA, and LA . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.