Device recall
Z-2343-2021: Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as…
FDA device recall · Class II · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-2343-2021 |
|---|---|
| Recall event | 88461 |
| Product | Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781342 |
| Product code | LNH |
| Recalling firm | Philips North America Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2023 |
| 510(k) numbers | K163116 |
| FEI number | 3016618143 |
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