OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified vie
FDA device recall Z-0105-2012 · posted 2011-10-24 · Terminated
Recall details
- Recalling firm
- Carl Zeiss Meditec, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- EPT
- Quantity affected
- 3
- Distribution
- USA (nationwide) including the states of FL, GA, and LA .
- Date initiated
- 2011-09-26
- Date posted
- 2011-10-24
- Date terminated
- 2011-11-04
- Location
- Dublin, CA
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