Spacelabs Healthcare Pulls Anesthesia Workstations Over Excess CO2 Risk
3/28/2013 9:07:11 AM
The FDA puts its highest-risk label on Spacelabs Healthcare's anesthesia workstation recall over concerns that a defect resulting in excess carbon dioxide concentration in inhaled gas may lead to patient harm or even death. Washington-based Spacelabs Healthcare recalled a slate of its Spacelabs BleaseSirius and BleaseFocus anesthesia workstations as well as certain absorbers contained in service kits over concerns that they may contain a defect which could result in excess carbon dioxide in the gas delivered to a patient. The FDA slapped the recall with Class I status, generally reserved for the highest-risk device defects, over concerns that excess carbon dioxide inhalation "may cause serious adverse health consequences, including death."