Device recall
Z-2483-2021: EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2…
FDA device recall · Class II · Philips Ultrasound Inc
Key facts
| Recall number (Z-number) | Z-2483-2021 |
|---|---|
| Recall event | 88514 |
| Product | EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231 |
| Product code | IYO |
| Recalling firm | Philips Ultrasound Inc |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K182857 |
| FEI number | 3019216 |
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