Puritan Bennett 980 Series Ventilator -Ventilator (2018-09-20)
- Starting date:
- September 20, 2018
- Posting date:
- November 2, 2018
- 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-68158
Affected products
Puritan Bennett 980 Series Ventilator - Ventilator
Reason
Medtronic is issuing a Software update (Maintenance Release MR 5.4) to enhance the functionality of PB980 ventilators and correct the concerns raised by TGA (Australia's Therapeutic Goods Administration. The concerns raised by TGA surround External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation.
Affected products
Puritan Bennett 980 Series Ventilator - Ventilator
Lot or serial number
All lots
Model or catalog number
- 980S1ENDICU
- 980S1FRDICU
- 980S3ENDICU
- 980S3FRDICU
- 980U1ENDICU
- 980U1FRDICU
- 980U3ENDICU
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES