Class 2 Device Recall Component for Laser Scanning Microscopes

• Date Initiated by Firm: October 02, 2019
• Create Date: April 06, 2020
• Recall Status: Terminated on July 25, 2024
• Recall Number: Z-1629-2020
• Recall Event ID: 84163
• Product Classification: Microscopy laser instrument or accessory products - Product Code RIB
• Product: Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
• Code Information: (LSM 700, LSM 800 and LSM 900)
• FEI Number: 2431026
• Recalling Firm/ Manufacturer: Zeiss, Carl Inc; 1 Zeiss Dr; Thornwood NY 10594-1939
• Manufacturer Reason for Recall: When the user tilts the transmitted light arm of the microscope to the end of its axis range, laser safety can be bypassed and result in emission of class lIlb laser radiation. This issue arises when a ZEISS inverted stage stand (Axio Observer or Axio Vert) is used in as a component of the LSM 700, 800 and 900 system
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: The Company will immediately notify by fax or direct contact (when available) and/or express courier each consignee purchaser and/or known user site with the laser safety notice which advises of the issue, the risk involved and how to minimize the risk of occurrence.
• Quantity in Commerce: US: 600; Global: 1600
• Distribution: Worldwide Distribution - US Nationwide
• 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.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.