Agency classClass IIOur severity:High FDA (Devices)·Z-0518-2020·Announced 2019-12-04

Becton Dickinson Recalls Site~Rite 8 Ultrasound Systems Due to Battery Indicator Defect

Becton Dickinson is recalling 2,215 Site~Rite 8 Ultrasound Systems because the battery indicator may falsely show charge, causing abrupt shutdowns without warning.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (abrupt shutdown during diagnostic imaging) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Becton Dickinson & Company is recalling 2,215 units of the Site~Rite 8 Ultrasound System, intended for diagnostic ultrasound imaging of the human body. The recall covers multiple catalog numbers, including 9770500, 9770501, 9770550 through 9770555, and 9770600 series consoles, in both new and refurbished configurations. The affected units were distributed nationwide and in foreign markets including the UK, Belgium, Australia, Japan, Canada, and others.

The recall was initiated because the battery indicator may show available charge when the battery is close to depletion. As a result, the device has the potential to abruptly shut down without advance warning to the user when running on battery power only. This defect could interrupt diagnostic procedures.

Healthcare facilities and users should stop using the affected units on battery power and contact Becton Dickinson for instructions on repair or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: 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…
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Diagnostic Imaging
Hazard: battery-indicator-failure
unexpected-shutdown
Affected units: 2,215

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Serial numbers

Distribution

Distributed nationwide across the United States.

Same manufacturer · Becton Dickinson & Company

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Same hazard · battery indicator failure