Model Number — Class II medical device recall Z-1809-2014
Terminated recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), reported 2014-06-25, distributed nationwide. In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to pro
| Recall number | Z-1809-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder, CO, United States |
| Recall initiated | 2014-06-04 |
| Classified | 2014-06-17 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2016-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 7,371 |
| Lot numbers | 1008J, 1009J, 1010J, 1018K, 1019K, 1020K, 1021K, 1022K, 1023K, 1030L, 1031L, 1032H, 1032L, 1033L, 1034L, 1035L, 1041H, 1042H, 1043H |
| Serial numbers | 3510012377, 4200000001 |
| Model numbers | 4-079056-00, PB840 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1809-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.