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U.S. Department of Health and Human Services

Class 2 Device Recall SiteRite 8 Ultrasound Systems

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  Class 2 Device Recall SiteRite 8 Ultrasound Systems see related information
Date Initiated by Firm November 04, 2019
Create Date November 23, 2019
Recall Status1 Terminated 3 on November 19, 2020
Recall Number Z-0518-2020
Recall Event ID 84262
510(K)Number K152554  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
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
Code Information All Serial numbers
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact SAME
201-847-6800
Manufacturer 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 Determined
Cause 2		 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 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.
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = C.R. Bard, Inc.
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