Known Identifiers & Locations
FEI Numbers
2936999
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0112-2015 |
Covidien Puritan Bennett 980 Ventilator, Rx ONLY.
Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Reason: A software issue may lead to ventilator inoperative situations.
|
2014-10-01 |
Terminated
|
View Details
|
| Z-0180-2015 |
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Reason: Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.
|
2014-10-01 |
Terminated
|
View Details
|
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.