Home / Recalls / GE Healthcare Biosciences / Z-0388-2019

Z-0388-2019 Class II Terminated

Recalled by GE Healthcare Biosciences — Westborough, MA

Recall Details

Product Type
Devices
Report Date
November 28, 2018
Initiation Date
September 10, 2018
Termination Date
May 12, 2020
Voluntary/Mandated
FDA Mandated
Product Quantity
39

Product Description

DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.

Reason for Recall

Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.

Distribution Pattern

Worldwide - US Nationwide Distribution

Code Information

System Serial number OM20072 - OM40122