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Terminated

SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

FDA Recall Z-0107-2019 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodePHC
Date Initiated2018-09-18
Date Terminated2020-08-19
Product Quantity354 units

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

NJ

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018-05-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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