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FDA Medical Device Recalls (openFDA)

Zeiss, Carl Inc: Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope

Recall number
Z-2441-2018
Recalling firm
Zeiss, Carl Inc
Product
Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
Status
Terminated
Initiated
2018-05-29
Posted
not on file
Terminated
2024-07-26
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
Lot, serial or model codes
432332-9020-000
510(k) numbers
not on file
PMA numbers
not on file
Product code
RGW
Firm FEI
2431026
Firm city
Thornwood
Firm state
NY
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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