Recall Z-0518-2020 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
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 S
| Date | Nov 4, 2019 |
| Status | Terminated |
| Reason | 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 |
| 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 i |
| Quantity | 2215 units |
| Distribution | Nationwide Foreign: UK, Belgium, Australia, Japan, Canada, Taiwan, Colombia, Chile, Philippines, Thailand, Brazil, Hong Kong, Chile, Argentina, Mexico, India, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc., Dec 14, 2015 |