Puritan Bennett 980 Ventilator System recall
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who…
Why was Puritan Bennett 980 Ventilator System recalled?
Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all versions of software.
- Product
- Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who…
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Quantity
- 1,864 units
- Distribution
- Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Russia, Uruguay, Slovenia, Morocco, Argentina, Egypt, and Romania.
- Recall date
- March 23, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)