FDA Device recall Z-2103-2023
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
- FDA Device
- Class I
- ongoing
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class I recall of SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2103-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-06-15 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
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.
Identifiers
| code_info | GTIN 00085412498683, Software version v8.01.01, Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2103-2023%22
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