Device recall
Z-0865-05: Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01)…
FDA device recall · Class II · Philips Ultrasound, Inc.
Key facts
| Recall number (Z-number) | Z-0865-05 |
|---|---|
| Recall event | 32064 |
| Product | Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01) |
| Product code | DPW |
| Recalling firm | Philips Ultrasound, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2008 |
| 510(k) numbers | K002186 |
| FEI number | 3019216 |
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