Device recall
Z-0518-2020: Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the…
FDA device recall · Class II · Becton Dickinson & Company
Key facts
| Recall number (Z-number) | Z-0518-2020 |
|---|---|
| Recall event | 84262 |
| 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… |
| Product code | IYO |
| Recalling firm | Becton Dickinson & Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 2020 |
| 510(k) numbers | K152554 |
| FEI number | 2243072 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database