FDA Recalls Spacelabs Healthcare's Anesthesia Workstations

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

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars