Longmont, Colorado - Sonora Medical Systems, a leading supplier of aftermarket products, services and test equipment to the medical imaging market, is issuing a warning to hospitals that at least one third-party ultrasound service company has illegally modified the FirstCall probe testing software in an attempt to test probe models that have never been validated by the Sonora engineering department through its ISO13485 and FDA/QSR processes.

These illegal software modifications may cause significant damage to the probes that are being tested, with the hospital then being told that the probes need to be replaced, according to the company.

"Hospitals should not allow third parties to test their probes with a FirstCall device unless that third 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 U.S. 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 the company will inform them of the status of that FirstCall.

For additional information concerning Sonora's FirstCall product, visit www.4sonora.com.

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