Class 1 Device Recall Dose IQ Safety Software

• Date Initiated by Firm: July 07, 2021
• Date Posted: August 11, 2021
• Recall Status: Terminated on June 20, 2024
• Recall Number: Z-2165-2021
• Recall Event ID: 88246
• 510(K)Number: K173084
• Product Classification: Pump, infusion - Product Code FRN
• Product: Dose IQ Safety Software used with Spectrum IQ Infusion Pump
• Code Information: Software version: All libraries initially created with version 9.0.x
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer Reason for Recall: Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.
• FDA Determined Cause: Software design
• Action: The firm issued an Urgent Medical Device Correction notice by letter on July 7, 2021. The letter explained the issue and provided a temporary workaround which can be implemented until the new software tool is ready for distribution.
• Quantity in Commerce: 61 units
• Distribution: US Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN