Reported Nov 28, 2018 · Terminated

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

GE Healthcare Biosciences

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare Biosciences · 14 Walkup Dr · Westborough, MA · 01581-1019

Is this the product you have?

  • DeltaVision
  • OMX SR Imaging System Model Number29115476 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
Lot codes and dates
  • System Serial number OM20072 - OM40122
Amount recalled
39

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 12, 2020 · Data as of Sep 19, 6:53 PM UTC

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