Sonora Medical Systemsissued a warning letter to medical facilities and on its website that at least one third-party ultrasound service company has illegally modified the FirstCall probe testing software in an attempt to test probes that have never been validated by Sonora.
From the Warning Letter:
Hospitals should not allow 3rd parties to test their probes with a FirstCall device unless that 3rd party has a Sonora Certificate that validates the software they are using along with a current calibration sticker on the device itself.” said G. Wayne Moore, President and CEO of Sonora Medical. “We have alerted the US Food and Drug Administration to this issue and will take all possible measures to alert hospital biomedical engineers of this illegal activity. If there is any question at all concerning the validity of a given FirstCall the biomedical engineer can call Sonora toll free at 1-888-4Sonora and we will inform them of the status of that FirstCall” he continued.
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