Recalled product is a component of the Newport Medical Instruments… — Class II medical device recall Z-1577-2014
Terminated recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), reported 2014-05-21, distributed in AZ, CA, CO, CT, FL, GA, KY, MA…. Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as
| Recall number | Z-1577-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder, CO, United States |
| Recall initiated | 2014-04-18 |
| Classified | 2014-05-09 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2016-03-01 |
| Distributed | AZ, CA, CO, CT, FL, GA, KY, MA, MD, MO, NV, PA, RI, TX, VA, WA |
| Countries outside the US | AE, BD, BE, BG, BO, BR, CL, CN, CO, DE, DO, DZ, EC, EG, FR, GB, GR, HK, HN, ID, IE, IL, IN, JP, KE, LB, LK, LT, MA, MX, NI, NL, NP, PA, PE, PH, PK, PL, PY, RU, SA, SG, SI, TH, TN, TR, TW, UY, VN |
| Quantity | 5,765 |
| Serial numbers | N11360719000 |
| Model numbers | E360, SBC2105A |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1577-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.