OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro Multivision/NC4, OPMI Vario/NC

FDA device recall Z-3275-2011 · posted 2011-09-23 · Terminated

Recall details

Recalling firm

Carl Zeiss Meditec, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

EPT

Quantity affected

1677 consignees

Distribution

Nationwide distribution: USA only.

Date initiated

2011-09-12

Date posted

2011-09-23

Date terminated

2012-02-24

Location

Dublin, CA