Event not reported on any specific serial numbers.For the reported event, ge healthcare (gehc) reported a field modification for this issue per 21 cfr 806 on 25 july 2019.The gehc internal field modification number is fmi 34101.Customers were sent a letter explaining the issue and were informed that if they choose to connect ge healthcare anesthesia device serial ports to tcp/ip networks, they should ensure that sufficiently secured terminal servers are used.Secure terminal servers provide robust security features that will prevent this issue.
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