Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for
FDA device recall Z-2329-2015 · posted 2015-08-14 · Terminated
Recall details
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Reason for recall
- Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
- Action taken
- Consignees will be notified via letter on July 17, 2015. No products will be returned, the reconfiguration of affected ventilators will occur at customer sites.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 657 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuw
- Date initiated
- 2015-07-16
- Date posted
- 2015-08-14
- Date terminated
- 2016-06-02
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM (K131252) | Covidien | 2014-02-24 |