Recall record at a glance
| Official record | Z-1577-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Report date | May 21, 2014 |
| Recall initiation date | Apr 18, 2014 |
| Quantity | 5,765 |
| Location | Boulder, CO, United States |
Official product description
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.
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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