FDA Device recall Z-1844-2014
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory su…
- FDA Device
- Class II
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class II recall of Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory su… by Nellcor Puritan Bennett Dba Covidien, citing covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display inf….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1844-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-03 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nellcor Puritan Bennett Dba Covidien |
| Distribution | US |
Product
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.
Reason
Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.
Identifiers
| code_info | serial number 3510100714 to 3512101160 and any units in which a replacement PSU was installed between March 2010 and September of 2010. |
|---|
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-1844-2014%22
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