Recall – Respiratory monitoring systems may have incorrect calibration

Company: CareFusion 303, Inc.
Date of Enforcement Report: 9/11/2019
Class II

PRODUCT

Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933

  • Recall Number: Z-2443-2019

REASON

Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2

RECALLING FIRM/MANUFACTURER

CareFusion 303, Inc. on 7/1/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

76 EtCO2 units

DISTRIBUTION

US Nationwide and Australia

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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