FDAClass IIAugust 27, 2014

IntelePACS software versions 3-8-1 to 4-9-1 recall

IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such…

Why was IntelePACS software versions 3-8-1 to 4-9-1 recalled?

In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated.

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?

software versions 3-8-1 to 4-9-1

Product
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such…
Recalling firm
Intelerad Medical Systems
Quantity
230
Distribution
Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
Recall date
August 27, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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