Class I Recall of Medtronic's Puritan Bennett980 (Pb980) Ventilator Series

Published: 12/20/2018

  • Food and Drug Administration
Relevant To:
  • Critical Access Hospitals,
  • Hospitals,
  • Long Term Care,
  • Ambulatory Care

Medtronic is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett™ 980 (PB980) ventilator series. Medtronic initiated this field action on September 19, 2018.

A Puritan Bennett 980 ventilator is a mechanical ventilator used to support a patient’s breathing. This prescription device is operated by trained healthcare professionals in an acute and or critical care clinical setting for neonatal, pediatric and adult patients.

The voluntary field corrective a

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