FDA Issues Recall for Spacelabs Healthcare's Xhibit Device Due to Audio/Video Failures
The FDA has announced a Class 2 device recall for Spacelabs Healthcare's Xhibit Central Station, a device used for remote surveillance of patient data. The recall was initiated due to failures in the DisplayPort audio/video splitter component, which can result in loss of audio, video, or both at the local Xhibit Central Station and extended displays. The recall affects the DisplayPort Splitter, Model number 010-1975-00, and customers have been instructed to discontinue its use. Spacelabs Healthcare has sent an 'URGENT MEDICAL DEVICE CORRECTION' letter to customers, advising them to notify relevant personnel, dispose of affected components, and replace them following proper installation requirements. The recall impacts approximately 6,074 units distributed across the United States and several other countries.