Device recall
Z-0611-2014: Puritan Bennett 840 ventilator systems software part number 4-070212-85…
FDA device recall · Class I · Covidien
Key facts
| Recall number (Z-number) | Z-0611-2014 |
|---|---|
| Recall event | 67108 |
| Product | Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients. |
| Product code | CBK |
| Recalling firm | Covidien |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 29, 2016 |
| 510(k) numbers | K001646, K020357, K053388, K970460, K984535, K993071 |
| FEI number | 2936999 |
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