Reported Aug 27, 2014 · Terminated
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and…
Intelerad Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intelerad Medical Systems · 895 Rue De La Gauchetiere O · Montreal · N/A
Is this the product you have?
- IntelePACS software versions 3-8-1 to 4-9-1
- Product UsageIntelePACS 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
- Lot codes and dates
- software versions 3-8-1 to 4-9-1
- Amount recalled
- 230
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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