Recall Z-2441-2018 ยท RGW Uv/Ir Research
Zeiss, Carl Inc
Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
| Date | May 29, 2018 |
| Status | Terminated |
| Reason | Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users to harmful UV radiation. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | The Company will immediately notify by direct contact (when available) and/or express courier each first line purchaser and/or known user site with informing them of the risk, how to prevent it and the notice of action. The Company will dispatch factory trained service representatives to perform following actions: o Installation of Hot Fix # 14 (or newer) for ZEN 2.3 o Installation of Firmware 1 .209 (or newer) on nodes x l 5 and x l 9 (Main Controller 2) |
| Quantity | 8 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.