Device recall
Z-0815-2015: Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0…
FDA device recall · Class II · Philips Ultrasound, Inc.
Key facts
| Recall number (Z-number) | Z-0815-2015 |
|---|---|
| Recall event | 69790 |
| Product | Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316… |
| Product code | LLZ |
| Recalling firm | Philips Ultrasound, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2016 |
| 510(k) numbers | K132165 |
| 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