Friday, May 31, 2013

FDA Recalls GemStar Infusion Machine After Battery Problems

The FDA has issued a Class 1 Recall for a wide range of GemStar Infusion intravenous machine models, as reported by beckersasc.com

The recalled models, according to the American Society of Anesthesiologists, suffered issues wherein a drop in the battery voltage rendered the device unusable; the malfunction can also erase the history logs of the device’s on-board computer. The devices, which were manufactured between 1999 and 2013, are critical to patient care; an interruption in the service the machines provide can result in serious injury and death.


More info at fda.gov