Z-2104-2023 Class I Ongoing
FDA device recall Z-2104-2023 was initiated by Baxter Healthcare Corporation on Jun 15, 2023 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 19861 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 19, 2023
- Initiation Date
- Jun 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19861 units
Product description
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 pattern
US Nationwide distribution.
Code information
UDI/DI 00085412610900, Software Version v9.02.01, All Serial Numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2104-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026