Recall Z-1629-2020— Zeiss, Carl Inc
Class II · Terminated
Class II FDA medical device recall by Zeiss, Carl Inc, initiated 2019-10-02, terminated 2024-07-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900). 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.
- Recalling firm
- Zeiss, Carl Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-02
- Terminated
- 2024-07-25
- Firm location
- Thornwood, NY, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.