Device recall
Z-2484-2021: Affiniti 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-2484-2021 |
|---|---|
| Recall event | 88514 |
| Product | Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119 |
| 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