OPMI Pentero…

Date posted by the FDA

Sept. 23, 2011

Status

Terminated

Filed by

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.

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.

Distribution pattern

Nationwide distribution: USA only.

Quantity

1677 consignees

Codes and lots

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.

Recall started

Sept. 12, 2011

Device type

Microscope, Surgical

Root cause (FDA)

Pending

What the company told customers

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.

Recall number

Z-3275-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-3275-2011. The agency record governs; check it and the company before acting.