Z-0107-2019Class II

Spectrum Iq Infusion System with Dose Iq Safety Software, 3570009

Name: Z-0107-2019 Spectrum Iq Infusion System with Dose Iq Safety Software, 3570009
Creator: Baxter Healthcare Corporation
Published: 2018-09-18
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-09-18 / Terminated / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 on 2018-09-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0107-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-18
Posted: 2018-10-13
Terminated: 2020-08-19
Recalling firm: Baxter Healthcare Corporation
Product: Spectrum Iq Infusion System with Dose Iq Safety Software, 3570009
Product code: PHC Infusion Safety Management Software
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: The firm initiated their field correction by email on 09/14/2018. The notice alerted the consignee of the problem and stated that Baxter would be issuing a software update to correct the issue.
Quantity in commerce: 354 units
Distribution: NJ
Product codes and lots: UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0107-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0107-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-12

Product code PHC

K173084Class IISpectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation / cleared 2018-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)