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Nellcor Puritan Bennett Inc. (dba Covidien LP) Recalls
11 recalls on record · August 22, 2012 to December 17, 2014 · Medical Devices
Recalls by year
12
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 17, 2014Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Hazard: Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.
November 5, 2014Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospita
Hazard: A software issue may lead to ventilator inoperative situations.
August 20, 2014Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are
Hazard: Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.
August 20, 2014Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packa
Hazard: Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.
July 2, 2014Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-i
Hazard: 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.
June 25, 2014Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator:
Hazard: 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.
May 21, 2014Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number
Hazard: Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally.
January 29, 2014Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 an
Hazard: Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.
January 29, 2014Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxyge
Hazard: Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.
September 5, 2012Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single u
Hazard: Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
August 22, 2012Medical DevicesFDA
Nellcor Puritan Bennett Inc. (dba Covidien LP) recalls Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FE
Hazard: Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.