The U.S. Food and Drug Administration has issued a Class I Recall on Spacelabs Healthcare's BleaseSirius and BleaseFocus Anesthesia Workstations due to loose hardware in the CAS I/II Absorbers, which could cause the Bag-to-Vent switch to fail.
The faulty hardware could cause a leak from the absorber circuit, inhibiting proper ventilation when in bag mode.
More Articles on FDA Regulations:
FDA Approves Alternative Epilepsy Treatment
FDA Offers Guidance to Quicken Device Evaluation
FDA Recalls Medtronic Heart Device