Sonora Medical Systems, a supplier of after-market products and test equipment to the medical imaging market, has issued a warning to hospitals that at least one third-party ultrasound service company has illegally modified its FirstCall probe testing software.
The modification is in an attempt to test probes models that have never been validated by the Sonora engineering department through its ISO13485 and FDA/QSR processes, the company said.
The 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 Longmont, Colo.-based Sonora.
“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.
Moore added that the company alerted the FDA about the issue “and will take all possible measures to alert hospital biomedical engineers of this illegal activity.”