Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of c

FDA device recall Z-1744-2013 · posted 2013-07-17 · Terminated

Recall details

Recalling firm

Zeiss, Carl Inc

Reason for recall

Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambda) Plate.

Action taken

On May 28, 2013, Carl Zeiss Microscopy, LLC recalled a Polarizer Component due to Misaligned Full-Wave (Lambda) Plate. Carl Ziess Microscopy distributed notices to their customers via e-mail. Carl Zeiss Microscopy, LLC requests that all customers immediately discontinue the use of the component for any applications which rely on accurate color-change sequence results. Your service provider will contact you to schedule a visit in which a factory trained service technician will confirm the alignment of your Polarizer D component;s lambda plate. If it is defective, a new Polarizer D component will be installed. There will be no charge for this action. Should you have any questions related to this issue, please do not hesitate to the Carl Zeiss facility in New York by telephone 914-681-7815 or via email at ed.mancini@zeiss.com

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IBJ

Quantity affected

10

Distribution

Distributed in the states of MI, TX, SD, FL, GA, NY, and NY.

Date initiated

2013-05-28

Date posted

2013-07-17

Date terminated

2014-10-29

Location

Thornwood, NY