FDA Medical Device Recalls (openFDA)
Carl Zeiss Meditec, Inc.: OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4, OPMI Vario/NC33, OPMI Neuro/NC4, OPMI Neuro/NC4 Ceiling Mount. A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area.
- Recall number
- Z-3275-2011
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Product
- OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4, OPMI Vario/NC33, OPMI Neuro/NC4, OPMI Neuro/NC4 Ceiling Mount. A surgical microscope and accessories is an AC powered device intended for use during surgery to provide a magnified view of the surgical area.
- Status
- Terminated
- Initiated
- 2011-09-12
- Posted
- 2011-09-23
- Terminated
- 2012-02-24
- Reason
- Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is passed on to third party navigation systems.
- Root cause
- Pending
- Action
- The firm, Zeiss, sent an "IMPORTANT SAFETY ALERT FOR ZEISS SURGICAL MICROSCOPES" letter dated September 7, 2011, to all affected customers. The letter described the product, problem and action to be taken. The customers were instructed to use surgical drapes compatible with ZEISS surgical microscopes and always follow the instructions for use of the third party navigation system manufacturer for calibration, calibration verification and operation. In addition, the firm supplied customers with a supplement to their Zeiss surgical microscope user documentation and requested that they read the information and keep a copy with their original instructions also the customers were instructed to complete and return the Acknowledgement of Receipt form within 5 business days via fax to 1-866-809-6044 or USPS to Stericycle, Inc., Attn: Event 2480, 2670 Executive Dr. Suite A, Indianapolis, IN 46241. Should you have any questions about this Safety Alert, please contact your Carl Zeiss Customer Care representative at 1-888-871-7120.
- Quantity
- 1677 consignees
- Distribution
- Nationwide distribution: USA only.
- Lot, serial or model codes
- All-OPMI¿ Pentero¿, OPMI¿ Pentero¿ C, OPMI¿ Pentero¿ 900, OPMI¿ Vario/S8, OPMI¿ Vario/S88, OPMI¿ Neuro Multivision/NC4, OPMI¿ Vario/NC33, OPMI¿ Neuro/NC4, OPMI¿ Neuro/NC4 Ceiling Mount.
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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