The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2267-2014·Announced 2014-08-27

Intelerad IntelePACS Software Recall Due to Potential File Truncation Errors

Intelerad Medical Systems is recalling IntelePACS software versions 3-8-1 to 4-9-1 because partially truncated files may be incorrectly reported as complete.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software error that may lead to the misinterpretation of data integrity (reporting truncated files as complete), which is a significant functional defect but does not involve reported hospitalizations or structural vehicle defects, fitting the Moderate criteria for low-risk contamination or minor labeling/functional errors without reported harm.

Plain-English summary

Intelerad Medical Systems is recalling IntelePACS software versions 3-8-1 to 4-9-1. The recall involves 230 units distributed worldwide, including the United States, Scotland, Ireland, the United Kingdom, Canada, Australia, and New Zealand. IntelePACS is a medical device used to receive digital images and data from various sources such as CT scanners, MRI scanners, ultrasound systems, and other imaging devices.

The recall is issued because, in specific situations, a partially truncated file may be written to the IntelePACS server. In these cases, the InteleViewer software may still allow the file to be viewed and will incorrectly report to the user that the file is complete. This issue only occurs if a file is partially truncated.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.

The recalled product

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…
Manufacturer
Intelerad Medical Systems
Category
Medical Device — Software
Hazard
Affected units
230

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • software versions 3-8-1 to 4-9-1

Distribution

Distributed nationwide across the United States.

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