Company: Baxter Healthcare Corporation
Date of Enforcement Report: 07/13/2023
Class I
PRODUCT
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
Recall Number:
Z-2103-2023
REASON:
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.
RECALLING FIRM/MANUFACTURER:
Baxter Healthcare Corporation
VOLUME OF PRODUCT IN COMMERCE:
3306 units
DISTRIBUTION:
US Nationwide distribution.
