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U.S. Department of Health and Human Services

Class 2 Device Recall Polarizer D Fixed w/Rotating Red 1 lambda plate

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  Class 2 Device Recall Polarizer D Fixed w/Rotating Red 1 lambda plate see related information
Date Initiated by Firm May 28, 2013
Date Posted July 17, 2013
Recall Status1 Terminated 3 on October 29, 2014
Recall Number Z-1744-2013
Recall Event ID 65355
Product Classification Light, microscope - Product Code IBJ
Product Polarizer D Fixed w/Rotating Red 1 lambda plate.

Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
Code Information Model # 445226-0000-000
Recalling Firm/
Manufacturer		 Zeiss, Carl Inc
1 Zeiss Dr
Thornwood NY 10594-1939
For Additional Information Contact Ed Mancini
914-681-7815
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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
Quantity in Commerce 10
Distribution Distributed in the states of MI, TX, SD, FL, GA, NY, and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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