The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning PS500 of an Infinity Acute Care System (IACS) Workstation Critical Care (Evita Infinity V500) [Catalogue Number(s): 8416400, 8417400], manufactured by Draeger Medical.
According to the FDA, the battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
For details, please refer to the FDA website::
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2343-2015&w=08262015&lang=eng
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 August 2015