Another recall for Spacelabs Healthcare's Arkon anesthesia system

The FDA slaps Spacelabs Healthcare with a Class I recall of its Arkon anesthesia system due to a software bug.

The FDA slapped Spacelabs Healthcare with a Class I recall after the medical device company pulled 16 of is Arkon anesthesia delivery devices due to a software bug.

The recall, of the Arkon device equipped with version 2.0 software, involves devices sold to hospitals in North Carolina and South Carolina, according to the FDA. The Class I recall status denotes a problem that could cause serious injury or death.

Food & Drug Administration (FDA), Spacelabs Healthcare

News Well, Anesthesia, Recalls, Regulatory/Compliance

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