FDA Device recall Z-0107-2019
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 by Baxter Healthcare, citing if an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0107-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-18 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | NJ |
Product
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Reason
If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.
Identifiers
| code_info | UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0107-2019%22
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