—#167598

Product

SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

FDA product code: PHC — Infusion Safety Management Software
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K173084
Affected lot / code info: UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 711 Park Ave, Medina, New York 14103-1036

Distribution

Distribution pattern: NJ

Timeline

Recall initiated: 2018-09-18
Terminated: 2020-08-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167598. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.