Device recall
Z-2163-2024: SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen…
FDA device recall · Class I · Philips North America Llc
Key facts
| Recall number (Z-number) | Z-2163-2024 |
|---|---|
| Recall event | 94786 |
| Product | SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352. |
| Product code | MOS |
| Recalling firm | Philips North America Llc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K043147 |
| FEI number | 3016618143 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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