FDAClass IIFebruary 11, 2015

Puritan Bennett 980 Ventilator System recall

Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on…

Why was Puritan Bennett 980 Ventilator System recalled?

Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.

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 Puritan Bennett 980 ventilators

Product
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on…
Recalling firm
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Quantity
418 units
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Recall date
February 11, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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