Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1629-2020Class II

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

Carl Zeiss Microscopy, LLC / initiated 2019-10-02 / Terminated

Zeiss, Carl Inc began a recall of Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900) on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1629-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Carl Zeiss Microscopy, LLC
Product
Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
Product code
RIB Microscopy Laser Instrument Or Accessory Products
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
FDA root cause
Radiation Control for Health and Safety Act
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.
Quantity in commerce
US: 600; Global: 1600
Distribution
Worldwide Distribution - US Nationwide
Product codes and lots
(LSM 700, LSM 800 and LSM 900)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1629-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1629-2020Class IITerminatedFDA Mandated