Alerts Tracker – Medical Devices – Critical Priority 4/24/2024 4:07:44 AM 4/24/2024 4:07:44 AM McKesson Medical-Surgical—InfuTronix Nimbus Infusion Pumps: May Exhibit Multiple Potential Failure Modes; Manufacturer Removes from Market https://alerts.ecri.org/alerts/view/details/1656713 4/23/2024 5:04:33 PM Medtronic—SonarMed Air Wave Monitors: Software Anomaly May Fail to Detect Partial Obstruction [FDA Class I] https://alerts.ecri.org/alerts/view/details/1656773 4/23/2024 2:59:25 PM Medtronic—SonarMed Sensors Used with AirWave Monitors: May Fail to Detect Partial Obstruction [FDA Class I] https://alerts.ecri.org/alerts/view/details/1656764 4/23/2024 2:57:40 PM ​Elekta—Disposable Biopsy Needle Kits for Leksell Stereotactic Systems: May Contain Microscopic Debris Inside Biopsy Needle [FDA Class 1] https://alerts.ecri.org/alerts/view/details/1656756 4/23/2024 11:50:58 AM Fresenius Kabi—Ivenix Infusion System Software: May Exhibit Anomalies, Potentially Leading to Underdose, Overdose, or Delay in Therapy [FDA Class I] https://alerts.ecri.org/alerts/view/details/1656726 4/22/2024 1:45:19 PM Medtronic—StealthStation S8 Software: May Display Incorrect Data during Surgical Procedure https://alerts.ecri.org/alerts/view/details/1656722 4/22/2024 10:39:44 AM ​Philips—Allura Xper, Allura Centron, and Azurion Systems: May Exhibit Loss of Functionality [MHRA FSN 29249203] https://alerts.ecri.org/alerts/view/details/1656724 4/16/2024 8:21:19 AM Medtronic—HeartWare Ventricular Assist Device Systems: May Exhibit a Delay or Failure to Restart [Update] [MHRA FSN 29243508] https://alerts.ecri.org/alerts/view/details/1656686 4/11/2024 3:07:37 PM ​Cardinal Health—Cardinal Health Brand Monoject Luer-Lock Syringes and Cardinal Health Brand Monoject Enteral Syringes with ENFit Connection: Manufacturer Expands Product Hold to Include Additional China-Manufactured Plastic Syringes [Update] [FDA Class I] https://alerts.ecri.org/alerts/view/details/1656628 4/10/2024 9:01:28 AM