Device recall
Z-2015-2008: Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System…
FDA device recall · Class II · Philips Medical Systems
Key facts
| Recall number (Z-number) | Z-2015-2008 |
|---|---|
| Recall event | 48163 |
| Product | Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body. |
| Product code | IYN |
| Recalling firm | Philips Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 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