Device recall
Z-0135-2016: All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1…
FDA device recall · Class II · Philips Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0135-2016 |
|---|---|
| Recall event | 68228 |
| Product | All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or… |
| Product code | LNH |
| Recalling firm | Philips Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2016 |
| 510(k) numbers | K063559, K110151 |
| FEI number | 1218950 |
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