Z-2267-2014Class II

IntelePACS software versions 3-8-1 to 4-9-1

Name: Z-2267-2014 IntelePACS software versions 3-8-1 to 4-9-1
Creator: Intelerad Medical Systems
Published: 2014-07-03
License: https://open.fda.gov/license/

Intelerad Medical Systems Incorporated / initiated 2014-07-03 / Terminated / root cause: software

FDA source

Intelerad Medical Systems began a recall of 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... on 2014-07-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2267-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-03
Posted: 2014-08-19
Terminated: 2016-01-13
Recalling firm: Intelerad Medical Systems Incorporated
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: Intelerad sent an Urgent Recall for Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a new software release will be installed on the system. Afterwards, an audit will be run on the the entire PACS to identify all image data that may have been truncated. Customers were requested to complete and return the attached Client Response Form.
Quantity in commerce: 230
Distribution: Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
Product codes and lots: software versions 3-8-1 to 4-9-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2267-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2267-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-19

Product code LLZ

K083520Class IIIntelepacs, Model Version 3.X.xIntelerad Medical Systems Incorporated / cleared 2009-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)