Device recall
Z-3218-2026: Midmark IQvitals Zone, automatically and noninvasively measures systolic and…
FDA device recall · Class II · Midmark Corporation
Key facts
| Recall number (Z-number) | Z-3218-2026 |
|---|---|
| Recall event | 99641 |
| Product | Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624 |
| Product code | MWI |
| Recalling firm | Midmark Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161909 |
| FEI number | 1523530 |
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