Z-0518-2020Class II

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

Name: Z-0518-2020 Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8...
Creator: Becton Dickinson & Company
Published: 2019-11-04
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-11-04 / Terminated

FDA source

Becton Dickinson & Company began a recall of Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished... on 2019-11-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0518-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-04
Posted: 2019-11-23
Terminated: 2020-11-19
Recalling firm: Becton Dickinson & Co
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 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
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
Reason for recall: 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
FDA root cause: Under Investigation by firm
Action: BD issued to US consignees via FedEx beginning November 4, 2019 Urgent Medical Device Notification, stating reason for recall , health risk and action to take: Until the issue is resolved, it is recommended that all Site~Rite 8 Ultrasound Systems be operated using AC power at all times during use in a clinical procedure. If use of AC power is not practical for your clinical setting, we recommend the use of an external re-chargeable battery. The listing of batteries have been qualified for use with the Site~Rite 8 Ultrasound System and are available for purchase through common retailers were identified. If you have experienced an abrupt shutdown, please contact 1-800-296-4146 Opt. 1 to coordinate with BD to replace your battery or provide you with an external battery. 2. Please share this medical device notification with all users of the Site~Rite 8 Ultrasound System at your facility to ensure they are also aware of the issue. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form so that BD may acknowledge your receipt of this notification. 4. If you choose to purchase one of the above batteries independently, please contact BD Customer Service at [email protected]. Please include a copy of the purchase receipt, BD account number and serial number of affected unit to arrange for reimbursement. 5. If the above batteries are not available, please contact BD Customer Service for additional battery options. Contact Information: 1-800-290-1689 Monday Friday between 8:00am and 5:00pm (EST) in the United States.
Quantity in commerce: 2215 units
Distribution: Nationwide Foreign: UK, Belgium, Australia, Japan, Canada, Taiwan, Colombia, Chile, Philippines, Thailand, Brazil, Hong Kong, Chile, Argentina, Mexico, India, Singapore
Product codes and lots: All Serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0518-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0518-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code IYO

K152554Class IISite-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. / cleared 2015-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)