Recall: Spacelabs Healthcare pulls anesthesia workstations over excess CO2 risk

March 27, 2013 by Arezu Sarvestani

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.

Spacelabs Medical logo

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."

Sign up to get our free newsletters delivered right to your inbox.

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.