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Recall Observatory FDA recall evidence

Device product

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

Z-1744-2013

May 28, 2013

Class II

Product summary

Firm
Zeiss, Carl Inc
Event
Event 65355
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-1744-2013

Official wording

Reason: 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.

Code information: Model # 445226-0000-000

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.