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U.S. Department of Health and Human Services

Class 1 Device Recall Dose IQ Safety Software

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  Class 1 Device Recall Dose IQ Safety Software see related information
Date Initiated by Firm July 07, 2021
Create Date August 11, 2021
Recall Status1 Open3, Classified
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
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 2		 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = Baxter Healthcare Corporation
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