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Recall Observatory FDA recall evidence

Device product

Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)

Z-1629-2020

October 02, 2019

Class II

Product summary

Firm
Zeiss, Carl Inc
Event
Event 84163
Status
Terminated
Classification
Class II
Quantity
US: 600; Global: 1600
Official record key
device-enforcement:Z-1629-2020

Official wording

Reason: 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

Code information: (LSM 700, LSM 800 and LSM 900)

Distribution pattern: Worldwide Distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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