Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number S

FDA device recall Z-1577-2014 · posted 2014-05-09 · Terminated

Recall details

Recalling firm

Nellcor Puritan Bennett Inc. (dba Covidien LP)

Reason for recall

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

CBK

Quantity affected

5,765

Distribution

Worldwide Distribution -- USA, including the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Maryland, Missouri, Nevada, Pennsylvania, Rhode Island, Te

Date initiated

2014-04-18

Date posted

2014-05-09

Date terminated

2016-03-01

Location

Boulder, CO