Quantum Informatics - Viper Monitor, Physiological, Patient recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medical device software marketed without FDA clearance .

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.

Where it was distributed

California, Florida, Illinois, Arkansas, Georgia, Wisconsin, Arizona, Massechusetts, Missouri, Maryland, Colorado, Nebraska, Pennsylvania, New Hampshire, Washington, West Virginia, Texas, Virginia, Minnesota, Distric of Columbia, Ohio, Conneticut, New Jersey, Utah, North Carolina, Louisiana, Kentucky, New York, Kansas, South Carolina, Idaho, Tennessee, Oregon, Maine, Indiana, Oklahoma, New Mexico, North Dakota, Alabama, Michigan, Mississippi

AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMaineMichiganMinnesotaMissouriMississippiNorth Carolina