CLASS II Device recall · Reported 25 Jun 2014 · FDA Enforcement Report
Model Number(s): PB840 Ventilator recalled
Nellcor Puritan Bennett Inc. ( is recalling Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a, distributed nationwide in the US. The recall was initiated on 4 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1809-2014
- FDA event ID
- 68454
- Recalling firm
- Nellcor Puritan Bennett Inc. (, Boulder, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jun 2014
- FDA classified
- 17 Jun 2014
- Reported
- 25 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 4 Jun 2014 | Recall initiated by company | |
| 17 Jun 2014 | Classified by FDA | +13 days |
| 25 Jun 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - USA (nationwide) including the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia., and the countries of Canada and Japan.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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,
Where was it sold?
Worldwide Distribution - USA (nationwide) including the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia., and the countries of Canada and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nellcor Puritan Bennett Inc. (
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|---|---|---|---|---|---|
| Device | CLASS I | Covidien Puritan Bennett 980 Ventilator recalled | Nellcor Puritan Bennett Inc. ( | Other | Nationwide |
| Device | CLASS I | Covidien Puritan Bennett 980 Ventilator recalled | Nellcor Puritan Bennett Inc. ( | Device Malfunction | 17 states |
| Device | CLASS II | Vital Sync RMS 1.0 when loaded with v2.4 recalled | Nellcor Puritan Bennett Inc. ( | Device Malfunction | 8 states |
| Device | CLASS II | Vital Sync" VPMP & IM recalled by Nellcor Puritan Bennett Inc. ( | Nellcor Puritan Bennett Inc. ( | Device Malfunction | 8 states |
| Device | CLASS II | Puritan Bennett 840 Ventilator recalled | Nellcor Puritan Bennett Inc. ( | Device Malfunction | Nationwide |
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