Z-2267-2014 Class II Terminated
FDA device recall Z-2267-2014 was initiated by Intelerad Medical Systems on July 3, 2014 and is designated Class II. Reason for recall: 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 th… The recall status is terminated (terminated January 13, 2016). Affected quantity: 230.
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2014
- Initiation Date
- July 3, 2014
- Termination Date
- January 13, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 230
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
Code Information
software versions 3-8-1 to 4-9-1