Device recall
Z-3185-2011: The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen…
FDA device recall · Class II · Spacelabs Healthcare, Incorporated
Key facts
| Recall number (Z-number) | Z-3185-2011 |
|---|---|
| Recall event | 55319 |
| Product | The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations… |
| Product code | MHZ |
| Recalling firm | Spacelabs Healthcare, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 12, 2011 |
| 510(k) numbers | K082045 |
| FEI number | 3010157426 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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