Medical device recalls Moderate risk

GE Healthcare Biosciences recalls DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory…

Recall date
September 10, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0388-2019
FDA classification
Class II
Brand / firm
GE Healthcare Biosciences
Sold / distributed
Worldwide - US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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