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Terminated

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

FDA Recall Z-1629-2020 · Posted None

Recalling FirmZeiss, Carl Inc
Recall StatusTerminated
Product CodeRIB
Date Initiated2019-10-02
Date Terminated2024-07-25
Product QuantityUS: 600; Global: 1600

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

Firm Action

The Company will immediately notify by fax or direct contact (when available) and/or express courier each consignee purchaser and/or known user site with the laser safety notice which advises of the issue, the risk involved and how to minimize the risk of occurrence.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide Distribution - US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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