Health product recall

Puritan Bennett 980 Series Ventilator (2020-10-21)

Starting date:
October 21, 2020
Posting date:
November 6, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74259



Last updated:
2020-11-04

Affected Products

Puritan Bennett 980 Series Ventilator

Reason

Medtronic is releasing a software update, R7.1, for all models of Puritan Bennett 980 (PB980) Series Ventilators. The software will optimize the battery pack charge voltage level to improve overall battery pack reliability, alert and direct users to replace battery packs if a faulty battery cell contained within the battery pack is detected and alert users when a battery pack is past its useful-life or within 90 days of its end-of-usefullife. This software is being released in response to in-house lab observations and customer reports of overheating and/or thermal damage to the battery pack.

Affected products

Puritan Bennett 980 Series Ventilator

Lot or serial number

All lots.

Model or catalog number
  • 980S1ENDICU
  • 980S1FRDICU
  • 980S3ENDICU
  • 980U1ENDICU
  • 980U1FRDICU
  • 980U3ENDICU
Companies
Manufacturer

Covidien LLC

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES