Device recall
Z-0812-2018: 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL…
FDA device recall · Class II · ZOLL Medical Corporation
Key facts
| Recall number (Z-number) | Z-0812-2018 |
|---|---|
| Recall event | 79248 |
| Product | 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure… |
| Product code | CBK |
| Recalling firm | ZOLL Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 2018 |
| 510(k) numbers | K071526, K091238, K103318, K111473 |
| FEI number | 1220908 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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