Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592

Portrait Core Services Software version V1.2.0 Security Vulnerability

HealthCast "Vital Sync" Remote Patient Monitoring System which consists of:

Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

Brand Name: EDAN

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Change Healthcare Cardiology Hemo Software

Due to complaints, software update may cause software to unexpectedly shutdown.

Change Healthcare Cardiology Hemodynamics Software

Due to complaints, software update may cause software to unexpectedly shutdown.

Brand Name: Quantum Informatics - VIPER

Medical device software marketed without FDA clearance .

Brand Name: Quantum Informatics - VISION / LIVE VUE

Medical device software marketed without FDA clearance .

Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers:

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Welch Allyn CONNEX Accessory Power Management Stand:

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

McKesson Cardiology Hemo software

Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).