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Recall Observatory FDA recall evidence

Device product

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.

Z-0388-2019

September 10, 2018

Class II

Product summary

Firm
GE Healthcare Biosciences
Event
Event 81454
Status
Terminated
Classification
Class II
Quantity
39
Official record key
device-enforcement:Z-0388-2019

Official wording

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

Code information: System Serial number OM20072 - OM40122

Distribution pattern: Worldwide - US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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