FDA recall Z-2104-2023

Product

The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-06-15

Report date

2023-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2104-2023