The United States Food and Drug Administration (FDA) posted a medical device safety alert concerning the Alaris PC unit model 8000 and 8015 with Alaris Patient Controlled Analgesia (PCA) module model 8120 and Auto ID barcode scanner model 8600 manufactured by CareFusion.
The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.
According to the manufacturer, the Alaris PC unit (model 8000 and 8015) was recalled because the Alaris PC unit will produce an audible alarm and display a System Error message.
For details, please visit the following FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0534-2014&w=01012014&lang=eng
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 7 January2014