FDAFDA · Food and drugs·Recall number Z-2267-2014
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.
Published August 27, 2014 · Recall initiated: July 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intelerad Medical Systems
- Distributor
- Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
- Lot
- software versions 3-8-1 to 4-9-1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.