OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.
- Company
- Carl Zeiss Meditec Inc
- Recall Initiated
- September 26, 2011
- Posted
- October 24, 2011
- Terminated
- November 4, 2011
- Recall Number
- Z-0105-2012
- Quantity
- 3
- Firm Location
- Dublin, CA
Reason for Recall
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.
Distribution
USA (nationwide) including the states of FL, GA, and LA .
Lot / Code Info
Serial numbers: 6636101067; 6636101068; 6636101070.
Root Cause
Nonconforming Material/Component
Action Taken
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.
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