Recall – UV Disinfection unit

Company: Zeiss, Carl Inc.
Date of Enforcement Report: 7/25/2018
Class II:

PRODUCT
Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope

Recall Number: Z-2441-2018

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..

RECALLING FIRM/MANUFACTURER
Zeiss, Carl Inc., Thornwood, NYon 5/29/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8

DISTRIBUTION
Nationwide

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.