Device recall
Z-0522-2009: Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-0522-2009 |
|---|---|
| Recall event | 49065 |
| Product | Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body. |
| Product code | IYN |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 14, 2011 |
| 510(k) numbers | K031552 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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