Alerts Tracker – Medical Devices - Capital Equipment 4/25/2024 3:44:09 PM 4/25/2024 3:44:09 PM Xenex Disinfection Services—​LightStrike Blackout Curtains: No Longer Recommended as a Protective Barrier against UV/Ozone Exposure https://alerts.ecri.org/alerts/view/details/1656792 4/25/2024 12:51:25 PM Smisson-Cartledge Biomedical—ThermaCor 1200 Rapid Thermal Infusion Systems: Manufacturer Recommends Steps to Mitigate Potential Aluminum Ion Exposure [Update] https://alerts.ecri.org/alerts/view/details/1656788 4/25/2024 12:23:10 PM IBA—Proteus 235 ProteusPLUS and ProteusONE Proton Therapy Systems: Radiation Is Not Prevented When Safety Parameters Checked by the Beam Access Point Process Are Out of Tolerance https://alerts.ecri.org/alerts/view/details/1656786 4/25/2024 10:22:31 AM ​Belmont Medical Technologies—RI-2 and FMS 2000 Rapid Infusers and Hyperthermia Pumps: May Become Inoperative Due to Valve Wand Motor Looseness [ECRI Exclusive Hazard Report] https://alerts.ecri.org/alerts/view/details/1656783 4/24/2024 9:25:59 AM Draeger—Infinity M500 Docking Stations: May Not Be in Full Compliance with IEC Standards https://alerts.ecri.org/alerts/view/details/1656725 4/24/2024 8:55:17 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 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 Medtronic—Puritan Bennett 980 Ventilators: Software Anomaly May Cause Short Self-Test to Fail https://alerts.ecri.org/alerts/view/details/1656758 4/23/2024 1:42:10 PM Philips—Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal Ventilators: May Display a Battery Depleted or Loss of Power Alarm While Sufficient Power is Available [FDA Class I] [Update] https://alerts.ecri.org/alerts/view/details/1656747 4/23/2024 12:41:28 PM 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 Siemens—Artis Q, Artis Q.zen, and Artis zee Systems: X-Ray Tube May Not Be Sufficiently Cooled If Coolant Level Drops below a Certain Level [MHRA FSN 28603423] https://alerts.ecri.org/alerts/view/details/1656763 4/19/2024 4:54:45 PM Miltenyi Biotec—​CliniMACS Prodigy Systems: Chamber May Overfill during Use of CliniMACS Prodigy LP-TCRα/β-19 System Application [MHRA FSN 28138960] https://alerts.ecri.org/alerts/view/details/1656762 4/19/2024 4:30:38 PM FDA Recommends Following Manufacturer's Instructions for Safe Use of Electrical Operating Room Tables​ https://alerts.ecri.org/alerts/view/details/1656720 4/19/2024 10:39:39 AM Thermo Fisher Scientific/Life Technologies—​Software Running on Ion PGM DX Systems May Be Vulnerable to Exploitation https://alerts.ecri.org/alerts/view/details/1656749 4/19/2024 10:35:23 AM ​GE HealthCare—Centricity Radiology RA600 and Centricity Cardiology CA1000 Systems: Anonymize Option May Not De-Identify All Patient Data When Images Are Burned to CD/DVD https://alerts.ecri.org/alerts/view/details/1656734 4/18/2024 2:14:24 PM Ossur—Rheo Knee and Rheo Knee XC Prostheses: May Exhibit Unintended Device Warnings, Potentially Triggering Device Shutdown​ https://alerts.ecri.org/alerts/view/details/1656737 4/18/2024 1:12:27 PM Masimo—Rad-97 Pulse CO-Oximeters: May Fail to Power On [ECRI Exclusive User Experience Network] https://alerts.ecri.org/alerts/view/details/1656695 4/18/2024 11:53:48 AM Qiagen—EZ2 Connect MDx Instruments: Welding between Heater Cable and Heater Plate May Be Insufficient https://alerts.ecri.org/alerts/view/details/1656692 4/17/2024 8:10:52 AM Baxter—Voalte Nurse Call and NaviCare Nurse Call Systems: Vulnerability with Service Account Password May Exist https://alerts.ecri.org/alerts/view/details/1656541 4/17/2024 7:50:48 AM Abbott—Aveir VR​ Leadless Pacemakers: Electromagnetic Interference May Cause Mode Change https://alerts.ecri.org/alerts/view/details/1656729 4/16/2024 10:29:32 PM RaySearch—RayStation Treatment Planning Systems: Source to Skin or Surface Distance Calculation May Be Too High​ https://alerts.ecri.org/alerts/view/details/1656697 4/16/2024 7:20:32 PM ​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 Abbott—Alinity m: May Have Problems with Third-Party Universal Transport Medium Tubes​ https://alerts.ecri.org/alerts/view/details/1656701 4/15/2024 6:26:19 PM Siemens—Artis Q, Artis Q.zen, and Artis zee Systems: X-Ray Tube May Not Be Sufficiently Cooled If Coolant Level Drops below a Certain Level [Update] https://alerts.ecri.org/alerts/view/details/1656699 4/15/2024 1:46:39 PM FDA Advises of Federal Court Consent Decree against Philips Respironics https://alerts.ecri.org/alerts/view/details/1656657 4/15/2024 8:28:56 AM ​Baxter—pro+ Mattresses for Centrella Smart+, CareAssist, and Advanta 2 Beds: Failure Mode May Cause a Reduction in Performance of Microclimate Management Feature; Certain Mattresses Need to Be Reassessed Because of Inconsistencies in Service Records Associated with Previous Correction https://alerts.ecri.org/alerts/view/details/1656667 4/12/2024 5:47:30 PM ​GE HealthCare—Medtronic SpO2 Nellcor Cables Branded as GE Apex Pro CH/FH SpO2 Nellcor Cables: May Transfer SpO2 Data to ApexPro CH and FH Telemetry Systems as "X" without Providing Appropriate Alarm Notification https://alerts.ecri.org/alerts/view/details/1656662 4/12/2024 1:48:22 PM ​GE HealthCare—MAC VU360 Resting ECG: May Lose Connection to Hospital Network, Preventing Automatic Upload of Patient Records [ECRI Exclusive User Experience Network] https://alerts.ecri.org/alerts/view/details/1656641 4/12/2024 10:09:18 AM Smiths—Medfusion Model 3500 and Model 4000 Syringe Infusion Pumps: Manufacturer Recommends against Use of Cardinal Health Branded Monoject Syringes [MHRA FSN 29242780] https://alerts.ecri.org/alerts/view/details/1656689 4/12/2024 9:35:43 AM RaySearch—RayStation Treatment Planning Systems: Source to Skin or Surface Distance (SSD) Calculation May Be Too High​ [MHRA FSN 29225345] https://alerts.ecri.org/alerts/view/details/1656675 4/11/2024 9:04:44 PM Green Power—Lithium-Ion Batteries​: May Present Fire Risk [MHRA FSN 29242630] https://alerts.ecri.org/alerts/view/details/1656684 4/11/2024 3:28:30 PM 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 ​GE Healthcare—CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE B850, and CARESCAPE B650 Patient Monitors: May Lose Monitoring under Certain Conditions https://alerts.ecri.org/alerts/view/details/1656647 4/11/2024 2:51:29 PM Abbott—Aveir VR​ Leadless Pacemakers: Electromagnetic Interference May Cause Mode Change [MHRA FSN 29240940] https://alerts.ecri.org/alerts/view/details/1656682 4/11/2024 2:07:44 PM