Z-1629-2020 Class II Terminated
FDA device recall Z-1629-2020 was initiated by Zeiss, Carl Inc on October 2, 2019 and is designated Class II. 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 … The recall status is terminated (terminated July 25, 2024). Affected quantity: US: 600; Global: 1600.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- October 2, 2019
- Termination Date
- July 25, 2024
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- US: 600; Global: 1600
Product Description
Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
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
Distribution Pattern
Worldwide Distribution - US Nationwide
Code Information
(LSM 700, LSM 800 and LSM 900)