The FDA advises biomedical engineering, anesthesiology, and risk managers of the Class I Recall Spacelabs anesthesia workstations and service kits due to a defect in CAS I/II absorbers.
The defect in CAS I/II absorbers in the Spacelabs anesthesia workstations and service kits may cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. This product may cause serious adverse health consequences, including death. These products were manufactured and distributed from October 31, 2012 to January 15, 2013.
Used in the hospital environment and in locations not requiring mobility of the products, these products provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to deliver anesthetic vapor.
The company advises to immediately cease use of BleaseSirius and BleaseFocus anesthesia workstations shipped after October 31, 2012. Immediately cease use of service kits part numbers 12200902, 050-0659-00, and 050-0901-00 and any workstation containing a CAS I/II absorber from a service kit. Advise staff of this situation.
Customers may call Spacelabs Medical at (800) 522-7025 and select 2 for technical support.
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