FDA Device recall Z-1577-2014
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended t…
- FDA Device
- Class II
- terminated
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class II recall of Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended t… by Nellcor Puritan Bennett Dba Covidien, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1577-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-18 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nellcor Puritan Bennett Dba Covidien |
| Distribution | AZ, CA, CO, CT, FL, GA, KY, MA, MD, MO, NV, PA, RI, TX, VA, WA |
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.
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.
Identifiers
| code_info | Part Number: SBC2105A. Model Number(s): e360 Ventilator. Serial numbers N11360719000 through N14360426029. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1577-2014%22
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