Device recall
Z-0523-2009: Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-0523-2009 |
|---|---|
| Recall event | 49065 |
| Product | Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Product also marketed as Philips 4000 New Standard, Philips 4000 System and Multibeam System. According to the firm… |
| 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