Medical device recalls Moderate risk

Zeiss, Carl Inc recalls Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)

Recall date
October 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1629-2020
FDA classification
Class II
Brand / firm
Zeiss, Carl Inc
Sold / distributed
Worldwide Distribution - US Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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