Device recall
Z-0818-2015: Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps…
FDA device recall · Class II · Philips Ultrasound, Inc.
Key facts
| Recall number (Z-number) | Z-0818-2015 |
|---|---|
| Recall event | 69790 |
| Product | Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. |
| Product code | LLZ |
| Recalling firm | Philips Ultrasound, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2016 |
| 510(k) numbers | K140808 |
| FEI number | 3019216 |
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