Device recall
Z-0027-2014: P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz…
FDA device recall · Class II · SonoSite, Inc.
Key facts
| Recall number (Z-number) | Z-0027-2014 |
|---|---|
| Recall event | 66346 |
| Product | P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic… |
| Product code | IYO |
| Recalling firm | SonoSite, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2013 |
| 510(k) numbers | K113156, K130173 |
| 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