Device recall
Z-0350-2016: Philips Healthcare INTEGRIS H5000F/Allura 9F Model: 722017 Product Usage: The…
FDA device recall · Class II · Philips Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0350-2016 |
|---|---|
| Recall event | 70370 |
| Product | Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and… |
| Product code | OWB |
| Recalling firm | Philips Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 18, 2017 |
| 510(k) numbers | K033737, K041949 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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