Becton Dickinson & Company recalls Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound Sys…

Recall date

November 4, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0518-2020

FDA classification

Class II

Brand / firm

Becton Dickinson & Company

Sold / distributed

Nationwide Foreign: UK, Belgium, Australia, Japan, Canada, Taiwan, Colombia, Chile, Philippines, Thailand, Brazil, Hong Kong, Chile, Argentina, Mexico, India, Singapore

Why it was recalled

The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running on battery power only

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8 System,Catalog No.9770501R Site~Rite 8 Ultrasound System, Catalog No. 9770550 Site~Rite 8 Ultrasound System, Catalog No. 9770552 Site~Rite 8 Ultrasound System, Catalog No. 9770553 Site~Rite 8 Ultrasound System, Catalog No. 9770554 Site~Rite 8 Ultrasound System, Catalog No. 9770555 Site~Rite 8 Ultrasound System Console with Connector, Catalog No.: 9770600 Site~Rite 8 Ultrasound System Console with Connector, Refurbished, Catalog No: 9770600X Site~Rite 8 Ultrasound System Console with Connector (Remanufactured) Catalog No: 9770600Y