Recall Z-1744-2013— Zeiss, Carl Inc
Class II · Terminated
Class II FDA medical device recall by Zeiss, Carl Inc, initiated 2013-05-28, terminated 2014-10-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.. 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..
- Recalling firm
- Zeiss, Carl Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-28
- Terminated
- 2014-10-29
- Firm location
- Thornwood, NY, United States
Product description
Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.