| Date Initiated by Firm | May 29, 2018 |
|---|
| Create Date | July 19, 2018 |
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| Recall Status1 |
Terminated 3 on July 26, 2024 |
| Recall Number | Z-2441-2018 |
|---|
| Recall Event ID |
80418 |
| Product Classification |
Uv/ir research - Product Code RGW
|
| Product | Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope |
|---|
| Code Information |
432332-9020-000 |
| FEI Number |
2431026
|
Recalling Firm/
Manufacturer |
Zeiss, Carl Inc
1 Zeiss Dr
Thornwood NY 10594-1939
|
Manufacturer Reason
for Recall | 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. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 8 |
|---|
| Distribution | US Nationwide Distribution |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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