Reported Dec 4, 2019 · Terminated

Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound…

Becton Dickinson & Company

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Becton Dickinson & Company · 1 Becton Dr · Franklin Lakes, NJ · 07417-1815

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
9770501Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System
9770600Refurbished 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, Site~Rite 8 Ultrasound System Console with Connector
9770600YRefurbished, Catalog No: 9770600X Site~Rite 8 Ultrasound System Console with Connector (Remanufactured)
Lot codes and dates
  • All Serial numbers
Amount recalled
2215 units

Where it was sold

  • Nationwide

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 19, 2020 · Data as of Sep 19, 6:51 PM UTC

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