Spectrum Medical Ltd.: Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only devi

Hazard

Medical device software marketed without FDA clearance .

Details from the source

Reason for recall: Medical device software marketed without FDA clearance . Distribution: 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, Quantity: 156 systems Lot/code info: All software revisions/No UDI

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.