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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number: SBC2105A. Model Number(s): e360 Ventilator. Serial numbers N11360719000 through N14360426029.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Part Number: SBC2105A. Model Number(s): e360 Ventilator. Serial numbers N11360719000 through N14360426029.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1577-2014
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