FDA Device recall Z-1809-2014
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Invert…
- FDA Device
- Class II
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class II recall of Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Invert… by Nellcor Puritan Bennett Dba Covidien, citing in the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1809-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-04 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nellcor Puritan Bennett Dba Covidien |
| Distribution | US |
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 ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities
Reason
In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator.
Identifiers
| code_info | Display part number 4-079056-00; serial number 4200000001 to 3510012377 that have a 9.4 display. Lots 1032H,1041H,1042H…Display part number 4-079056-00; serial number 4200000001 to 3510012377 that have a 9.4 display. Lots 1032H,1041H,1042H,1043H,1008J,1009J,1010J,1018K,1019K,1020K,1021K,1022K,1023K,1030L,1031L,1032L,1033L,1034L,1035L, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1809-2014%22
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