Data Foundry

Medical device recalls 2014

IntelePACS software versions 3-8-1 to 4-9-1 — Class II medical device recall Z-2267-2014

Terminated recall by Intelerad Medical Systems, reported 2014-08-27, distributed nationwide. In specific situation a partially truncated file may be written to the IntelePACS server. This partially trunc

Recall numberZ-2267-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntelerad Medical Systems, Montreal, Canada
Recall initiated2014-07-03
Classified2014-08-19
Reported by FDA2014-08-27
Terminated2016-01-13
DistributedNationwide (US)
Countries outside the USAU, CA, GB, IE, NZ
Quantity230

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2267-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.