MASSDEVICE ON CALL — The FDA put its highest-risk stamp on Smiths Medical’s alarm cable recall, warning that a rare issue may cause patients harm or even death.
The BCI remote alarm cables are meant for use with Smiths Medical’s 9004 Capnocheck Capnography systems, transferring alarms from the system to a remote alarm system.
In rare cases the cables may not properly transfer alarms to some remote systems, resulting in missed warnings. The Capnocheck system provides monitoring in a variety of healthcare environments, including ventilator applications, patient transport, and anesthesia, according to the FDA report.
Smiths Medical in February 2013 issued a "Urgent Medical Device Field Safety Notice-Recall" to its customers, asking them to inspect their inventory and remove all affected devices from service.
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