Device recall
Z-0021-2011: The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is…
FDA device recall · Class II · Philips Medical Systems North America Co. Phillips
Key facts
| Recall number (Z-number) | Z-0021-2011 |
|---|---|
| Recall event | 56707 |
| Product | The BABIX holder is an accessory used with the BuckyDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination. |
| Product code | KPR |
| Recalling firm | Philips Medical Systems North America Co. Phillips |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2011 |
| 510(k) numbers | K945278 |
| 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