Recall – Displayed values incorrect due to software error

Company: GE Healthcare, LLC
Date of Enforcement Report: 1/22/2020
Class I

PRODUCT

CARESCAPE Respiratory Module E-sCO

  • Recall Number: Z-0754-2020

CARESCAPE Respiratory Module E-sCOVX

  • Recall Number: Z-0755-2020

CARESCAPE Respiratory Module E-sCAiO

  • Recall Number: Z-0756-2020

CARESCAPE Respiratory Module E-sCAiOV

  • Recall Number: Z-0757-2020

CARESCAPE Respiratory Module E-sCAiOE

  • Recall Number: Z-0758-2020

CARESCAPE Respiratory Module E-sCAiOVE

  • Recall Number: Z-0759-2020

Airway Gas Option N-CAiO

  • Recall Number: Z-0760-2020

 

REASON

Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 9/27/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

167 units

DISTRIBUTION

International

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.