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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Tampa, FL 33624
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Partners located in the US (CA, FL, MA, MN) and Italy.