Device recall
Z-1809-2014: Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component…
FDA device recall · Class II · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Key facts
| Recall number (Z-number) | Z-1809-2014 |
|---|---|
| Recall event | 68454 |
| Product | Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive… |
| Product code | CBK |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2016 |
| 510(k) numbers | K970460 |
| 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