Company:Ortho-Clinical Diagnostics Date of Enforcement Report 5/2/12 Class ll: PRODUCT 1) VITROS? ECi Immunodiagnostic System, Catalog No. 8633893 — COMMON/USUAL NAME: VITROS? ECi System. All systems that has Software Version 3.8 or below installed and on which the VITROS? Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic...Read More

Company:Viterion HealthcareDate of Enforcement Report 5/2/12 Class ll: PRODUCT Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Common Name: Viterion100 TeleHealth Monitor — Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The...Read More

Company:Scottcare Corp.Date of Enforcement Report 5/2/12 Class ll: PRODUCT TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01, Part #101086. The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection...Read More

Company:Viterion HealthcareDate of Enforcement Report 5/2/12 Class ll: PRODUCT 1) Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Product Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis...Read More