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Tag Archives: medical-device-recall

GE Healthcare Nuclear Medicine Systems: Class I Recall

GE Healthcare has issued a recall for several Nuclear Medicine Imaging Systems because of the possibility of serious injuries or death due to the failure mode associated with this recall. GE Healthcare became aware of an incident at the VA Medical Center facility in the U.S. A patient died due to injuries sustained while being -->

Medical Device Class I Recall: Lumenis Limited, Lumenis VersaCut Tissue Morcellator

According to the FDA on February 25, 2013, Lumenis Limited is recalling certain models of VersaCut Morcellator devices to correct its labeling. These devices break up and remove dissected tissue during surgical procedures when access to the surgical site is limited. There is a potential for air embolisms to occur if the aspiration tubing is -->

Class I Recall: DePuy Orthopaedics, Inc recalls LPS Diaphyseal Sleeve

According to the FDA on January 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. The LPS Diaphyseal Sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to -->