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U.S. Department of Health and Human Services

Class 3 Device Recall ZEISS Axio Observer 5 microscope

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  Class 3 Device Recall ZEISS Axio Observer 5 microscope see related information
Date Initiated by Firm June 24, 2022
Create Date July 25, 2022
Recall Status1 Completed
Recall Number Z-1465-2022
Recall Event ID 90554
Product Classification Microscope and microscope accessories, reproduction, assisted - Product Code MTX
Product ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Code Information UDI-DI: 4064897000075 Serial Number: 3859001079
Recalling Firm/
Manufacturer		 Zeiss, Carl Inc
1 Zeiss Dr
Thornwood NY 10594-1939
Manufacturer Reason
for Recall		 An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
FDA Determined
Cause 2		 Process control
Action On June 24, 2022, the firm notified their US customer of the recall via email. The customer was informed that a Zeiss service technician will contact them to arrange a date for performing a corrective action to eliminate the risk. The UDI label will be replaced.
Quantity in Commerce 1 US; 2 OUS
Distribution US Nationwide distribution in the state of 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.
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