Z-2103-2023 Class I Ongoing
FDA device recall Z-2103-2023 was initiated by Baxter Healthcare Corporation on June 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: 3306 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2023
- Initiation Date
- June 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3306 units
Product Description
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
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
GTIN 00085412498683, Software version v8.01.01, Serial Numbers