Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1744-2013Class II

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

Carl Zeiss Microscopy, LLC / initiated 2013-05-28 / Terminated / root cause: manufacturing process

Zeiss, Carl Inc began a recall of Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1744-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Carl Zeiss Microscopy, LLC
Product
Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
Product code
IBJ Light, Microscope
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.
Root cause tag
manufacturing process
FDA root cause
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 [email protected]
Quantity in commerce
10
Distribution
Distributed in the states of MI, TX, SD, FL, GA, NY, and NY.
Product codes and lots
Model # 445226-0000-000

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1744-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1744-2013Class IITerminatedVoluntary: Firm initiated