FDAClass IINovember 28, 2018

DeltaVision OMX SR Imaging System recall

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

Why was DeltaVision OMX SR Imaging System 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

System Serial number OM20072 - OM40122

Product
DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution…
Recalling firm
GE Healthcare Biosciences
Quantity
39
Distribution
Worldwide - US Nationwide Distribution
Recall date
November 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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