Drug recall
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital…
FDA recall event 68719 · Class II · Intelerad Medical Systems
Key facts
| Event ID | 68719 |
|---|---|
| Recall numbers | Z-2267-2014 |
| Recalling firm | Intelerad Medical Systems |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 3, 2014 |
| Report date | Aug 27, 2014 |
| Termination date | Jan 13, 2016 |
| City | Montreal |
| Country | Canada |
| FEI number | 3008437943 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: