CareFusion, a global medical device company, has issued update regarding its previously disclosed recall of approximately 17,000 Alaris PC units model 8015 manufactured or serviced between December 2008 and September 2009.
The US Food and Drug Administration has classified the action as a Class I recall, a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Reportedly, on 24 August 2010 CareFusion has sent an urgent Medical Device Recall Notification to customers of its Alaris PC unit model 8015 stating that under certain wireless network conditions, affected units may experience an intermittent communication error, which freezes the PC unit screen.
In the notification letter, customers were provided clinical tip sheets and informed of warning tags for each of the affected units and were also given instructions on how to temporarily or permanently disable the wireless mode of the PC unit setting to further mitigate the risk and CareFusion is conducting a field corrective action to update the hardware on affected PC units.