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U.S. Department of Health and Human Services

Class 2 Device Recall Compensator Slider Lambda 6x20 component

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 Class 2 Device Recall Compensator Slider Lambda 6x20 componentsee related information
Date Initiated by FirmDecember 20, 2013
Date PostedJanuary 21, 2014
Recall Status1 Terminated 3 on April 08, 2015
Recall NumberZ-0799-2014
Recall Event ID 67178
Product Classification Light, microscope - Product Code IBJ
ProductCompensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.
Code Information part number 473704-0000-000
FEI Number 2431026
Recalling Firm/
Manufacturer		 Zeiss, Carl Inc
1 Zeiss Dr
Thornwood NY 10594-1939
Manufacturer Reason
for Recall		Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCarl Zeiss, Inc. sent an Important Medical Device Corrective Action letter dated December 20, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that their service provider would contact them to schedule a visit in which a factory trained service technician would install a new Compensator Slider Lambida 6x20. Customers should return the old Compensator Slider to the factory for testing. Customers with technical questions were instructed to call 914-681-7815.
Quantity in Commerce335 units Total (14 domestically & 321 internationally)
DistributionWorldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Hong Kong, India, Italy, Kosovo, Lithuania, Mexico, The Netherlands, New Zealand, Peru, Poland, Spain, and Taiwan.
Total Product Life CycleTPLC 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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