Zeiss UV Disinfection Unit Recalled for Potential Radiation Exposure
Zeiss is recalling 8 UV disinfection units for the Celldiscoverer 7 microscope because a firmware issue may allow the unit to activate outside its housing, exposing users to harmful UV radiation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (UV radiation exposure) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zeiss, Carl Inc is recalling 8 units of the Disinfection unit UV (432332-9020-000) used with the Celldiscoverer 7 microscope. The recall was initiated due to a firmware defect that, under certain circumstances, allows the UV disinfection unit to activate while it is outside of the microscope's housing.
The primary hazard associated with this defect is the potential exposure of users to harmful ultraviolet (UV) radiation. The affected units were distributed nationwide in the United States.
Users of the Celldiscoverer 7 microscope should check their equipment for the specific model number 432332-9020-000. If the unit is identified as part of this recall, users should stop using the device and contact Zeiss, Carl Inc for instructions on how to proceed with the recall.
The recalled product
- Product
- Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
- Manufacturer
- Zeiss, Carl Inc
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 432332-9020-000
Distribution
Distributed nationwide across the United States.
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