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Recall Observatory FDA recall evidence

Device 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 as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.

Z-2267-2014

July 03, 2014

Class II

Product summary

Firm
Intelerad Medical Systems
Event
Event 68719
Status
Terminated
Classification
Class II
Quantity
230
Official record key
device-enforcement:Z-2267-2014

Official wording

Reason: 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.

Code information: software versions 3-8-1 to 4-9-1

Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.