FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0105-2012
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Product
- OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.
- Status
- Terminated
- Initiated
- 2011-09-26
- Posted
- 2011-10-24
- Terminated
- 2011-11-04
- 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 .
- Lot, serial or model codes
- Serial numbers: 6636101067; 6636101068; 6636101070.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EPT
- Firm FEI
- 2918630
- Firm city
- Dublin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28