World-wide medical device company CareFusion announced on August 24 that the screens of their Alaris PC unit model 8015 occasionally received communication errors and froze on wireless networks. The Food and Drug Administration has now classified the recall as Class I, the most serious type of recall. The unit, intended to assist with patient therapy, once frozen would prevent changes in inputting treatment plans for patients. This could result in potentially serious issues with providing health care to patients. A Class I recall implies there is a reasonable chance the product will cause “adverse health consequences or death” says a PR advisory.
Customers were provided instructions on how to disable wireless mode, which would hopefully help address the malfunction. CareFusion is in the process of a hardware update to potentially fix the affected PC’s, which include units manufactured or serviced between December 2008 and September 2009. No incidences of injury or death have yet to result from the malfunctioning, and the company says they will appropriate funds to create a plan of action.
If you or a loved one were affected by a recalled product, it is wise to be aware of cases like these where the FDA has issued a Class I status. Having a Los Angeles personal injury attorney at your service can ensure you gain the best possible compensation for your damages.