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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1629-2020 | Class II | Terminated | FDA Mandated |
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