On November 26, the FDA announced a Class I Recall due to a potential defect involving anesthesia workstations manufactured by Spacelabs Healthcare, Snoqualmie, Wash. According to the FDA, the bag-to-vent switch in CAS I/II absorbers used in the BleaseSirius and BleaseFocus workstations may fail due to loose fastening hardware.
In the worst case, the agency says, this could result in a large leak from the absorber circuit while operating in bag mode, impeding the ability to provide ventilation in bag mode. Operation in vent mode along with all monitoring and alarm functions will continue to operate normally.
Spacelabs sent sent an Urgent Medical Device Correction letter to all affected customers on November 1.