FDA recall Z-1629-2020

Product

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

Worldwide Distribution - US Nationwide

Key facts

Status

Terminated

Initiation date

2019-10-02

Report date

2020-04-15

Termination date

2024-07-25

Voluntary/Mandated

FDA Mandated

Location

Thornwood, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1629-2020