FDAClass IIDecember 4, 2019

Site~Rite 8 Ultrasound Systems-intended for diagnostic recall

Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500…

Why was Site~Rite 8 Ultrasound Systems-intended for diagnostic 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Serial numbers

Product
Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500…
Recalling firm
Becton Dickinson & Company
Quantity
2215 units
Distribution
Nationwide Foreign: UK, Belgium, Australia, Japan, Canada, Taiwan, Colombia, Chile, Philippines, Thailand, Brazil, Hong Kong, Chile, Argentina, Mexico, India, Singapore
Recall date
December 4, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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