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U.S. Department of Health and Human Services

Class 2 Device Recall SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE

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 Class 2 Device Recall SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWAREsee related information
Date Initiated by FirmSeptember 18, 2018
Create DateOctober 13, 2018
Recall Status1 Terminated 3 on August 19, 2020
Recall NumberZ-0107-2019
Recall Event ID 81158
510(K)NumberK173084 
Product Classification Infusion safety management software - Product Code PHC
ProductSPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
Code Information UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
711 Park Ave
Medina NY 14103-1036
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionThe 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.
Quantity in Commerce354 units
DistributionNJ
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PHC
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