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."
Spacelabs initiated the recall in January 2013, sending an urgent letter to call affected customers to warn them of the issue, according to the FDA notice. The company asked customers to cease using all BleaseSirius and BleaseFocus systems shipped after October 31, 2012, as well as all service kits numbered 12200902, 050-0659-00 or 050-0901-00 and any workstations containing such kits.
The anesthesia systems are used in hospital settings to provide respiratory support to patients, delivering a controlled flow of oxygen, air, and nitrous oxide via patient-breathing circuits, according to the FDA. The workstations may also delivery anesthetic vapor.
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