Becton Dickinson & Company 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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 capital_support@bardaccess.supportsystem.com. 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.