Device recall
Z-1818-2013: ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi…
FDA device recall · Class II · Sotera Wireless, Inc.
Key facts
| Recall number (Z-number) | Z-1818-2013 |
|---|---|
| Recall event | 65718 |
| Product | ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. |
| Product code | MWI |
| Recalling firm | Sotera Wireless, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2013 |
| 510(k) numbers | K112478, K122036 |
| FEI number | 3009673645 |
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