Device recall
Z-2191-2010: SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc…
FDA device recall · Class II · Sonosite, Inc.
Key facts
| Recall number (Z-number) | Z-2191-2010 |
|---|---|
| Recall event | 49374 |
| Product | SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021". The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or… |
| Product code | IYO |
| Recalling firm | Sonosite, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2011 |
| 510(k) numbers | K071134 |
| FEI number | 3002087856 |
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