Device recall
Z-1603-2011: Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering…
FDA device recall · Class II · Philips Medical Systems North America Co. Phillips
Key facts
| Recall number (Z-number) | Z-1603-2011 |
|---|---|
| Recall event | 57611 |
| Product | Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety surgical and non-surgical applications including; cerebral, thoracic, abdominal, peripheral, orthopedic, cardiac, and vascular procedures. |
| Product code | IZL |
| Recalling firm | Philips Medical Systems North America Co. Phillips |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2012 |
| 510(k) numbers | K010762 |
| FEI number | 1000524572 |
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