Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
Zeiss, Carl Inc began a recall of Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-2441-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Carl Zeiss Microscopy, LLC
- Product
- Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
- Product code
- RGW Uv/Ir Research
- 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.
- Root cause tag
- software
- FDA 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 in commerce
- 8
- Distribution
- US Nationwide Distribution
- Product codes and lots
- 432332-9020-000
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2441-2018 | Class II | Terminated | FDA Mandated |
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