Recall Z-1629-2020 ยท RIB Microscopy Laser Instrument Or Accessory Products
Zeiss, Carl Inc
Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)
| Date | Oct 2, 2019 |
| Status | Terminated |
| Reason | 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 |
| 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 | US: 600; Global: 1600 |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.