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U.S. Department of Health and Human Services

Class 1 Device Recall Spectrum IQ Infusion System with Dose IQ Safety Software

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 Class 1 Device Recall Spectrum IQ Infusion System with Dose IQ Safety Softwaresee related information
Date Initiated by FirmJune 04, 2021
Create DateAugust 06, 2021
Recall Status1 Completed
Recall NumberZ-2110-2021
Recall Event ID 88073
510(K)NumberK173084 
Product Classification Pump, infusion - Product Code FRN
ProductSpectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact
800-422-9837
Manufacturer Reason
for Recall		System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in excessive Spectrum IQ pump connectivity errors.
FDA Determined
Cause 2		Software design
ActionBaxter initiated the recall by letter on 06/04/2021. The letter described the problem and the hazard involved, and requested the consignee Baxter Technical Assistance in advance of making changes to your network or server infrastructure supporting the pumps or the Baxter Gateway, as indicated in Baxter's Gateway Server Installation Handoff document which customers receive upon installation. The firm is developing a software patch for all Spectrum IQ infusion pumps.
Quantity in Commerce130135 units
DistributionUnited States (including Puerto Rico), Canada, Bahamas, Bermuda, Guyana, and Trinidad and Tobago.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = FRN
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