FDA Medical Device Recalls (openFDA)
Nellcor Puritan Bennett Inc. (dba Covidien LP): Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.
- Recall number
- Z-1577-2014
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Product
- Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.
- Status
- Terminated
- Initiated
- 2014-04-18
- Posted
- 2014-05-09
- Terminated
- 2016-03-01
- Reason
- 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.
- Root cause
- Component design/selection
- Action
- Newport Medical Instruments, Inc. (Newport), a wholly-owned subsidiary of Covidien is conducting a voluntary field corrective action via letters to be sent during the week of April 28, 2014. The letter titled "URGENT MEDICAL DEVICE FIELD SAFETY CORRECTIVE ACTION" informed customers of the recall by providing: reason for recall, product description, information on affected serial numbers regardless of software versions, issue identified, recommended actions to help mitigate risk to the patient, actions to eliminate the occurrence of this issue, important safety reminders, and contact information. Customers are to contact Technical Support Department to receive a software update kit, and then follow the instructions provided once the kit has been received. The attached verification and completion form should be completed and faxed.
- Quantity
- 5,765
- Distribution
- Worldwide Distribution -- USA, including the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Maryland, Missouri, Nevada, Pennsylvania, Rhode Island, Texas, Virginia, and Washington; and, the countries of Algeria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, England, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Japan, Kazakhstan, Kenya, Lebanon, Liechtenstein, Lithuania, Mexico, Morocco, Namibia, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Republic of Armenia, Republic of KOS, Russia, Saudi Arabia, Singapore, Slovenia, S. Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Vietnam, and Yemen.
- Lot, serial or model codes
- Part Number: SBC2105A. Model Number(s): e360 Ventilator. Serial numbers N11360719000 through N14360426029.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2936999
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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