The United States Food and Drug Administration (FDA) has posted a medical device safety alert issued by medical device manufacturer, Carefusion Corporation, concerning its Alaris PC unit model 8015 with software version 9.12.
According to the manufacturer, the recall was initiated because the manufacturer has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
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-1098-2013&w=04242013&lang=eng
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 April 2013