Nellcor Puritan Bennett Inc. (dba Covidien LP): Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.

Recall number

Z-0822-2014

Recalling firm

Nellcor Puritan Bennett Inc. (dba Covidien LP)

Product

Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.

Status

Terminated

Initiated

2013-01-25

Posted

2014-01-24

Terminated

2014-11-24

Reason

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.

Root cause

Labeling Change Control

Action

The firm, Covidien, sent an "URGENT MEDICAL DEVICE VOLUNTARY FIELD CORRECTION" letter dated January 24, 2014 to its Consignees/customers via certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to read and understand the enclosed information; communicate this information to those who need to be aware of this labeling update; for the Puritan Bennett 840 ventilator only: If you have addendum P/N 066009A 09/02, remove and discard the addendum and replace it with the new information in Attachment I; for the Puritan Bennett 740 and 760 ventilators only: Add the new information in Attachment I; Ensure all O2 sensors in use or in inventory conform to the instructions in this notification. to your current operators manual and service manual, and read and understand the warnings, cautions and notes related to safety, ventilator use and operation that are contained in the Preface of the Operators Manuals. are asked to remove incorrect labeling and replace with the revised labeling. Covidien enclosed a labeling update (Attachment I) which provides detailed information related to the life of oxygen sensors used with the Puritan Bennett 840, 740 and 760 ventilators. Covidien has validated another oxygen sensor, P/N 10097559, for use in the Puritan Bennett 840, 740 and 760 ventilators. Information about that sensor is also included in the update in Attachment I. Should you have any questions regarding this letter or to report any issues with the Puritan Bennett" 840, 740 or 760 ventilators contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1, to ensure proper device reporting procedures are followed.

Quantity

7,959

Distribution

Worldwide Distribution: US (nationwide) and Internationally to: Albania, Argentina, Australia, Bahrain, Belgium, Belize, Bermuda Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, The former Yugoslav, Malaysia, Mexico, Moldova, Republic of, Montenegro, Morocco, Netherlands, Nicaragua, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukrainian SSR, United Arab Emirates (UAE) United Kingdom, Uruguay, Venezuela and Yugoslavia.

Lot, serial or model codes

PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389

510(k) numbers

["K964540","K970460","K984379","K990897"]

PMA numbers

not on file

Product code

CBK

Firm FEI

2936999

Firm city

Boulder

Firm state

CO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy