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U.S. Department of Health and Human Services

Class 2 Device Recall Volumat MC Agilia

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  Class 2 Device Recall Volumat MC Agilia see related information
Date Initiated by Firm December 02, 2017
Create Date November 02, 2018
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-0362-2019
Recall Event ID 81208
510(K)Number K121613  
Product Classification Pump, infusion - Product Code FRN
Product Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required).
Code Information Model Catalog Z021135
Recalling Firm/
Manufacturer		 Fresenius Vial Sa
Le Grand Chemin
Brezins France
Manufacturer Reason
for Recall		 Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common software malfunctions.
FDA Determined
Cause 2		 Software design
Action A recall notification dated 11/17/17 was sent to customers to inform them that Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump. The new software version 1.9a is currently available and designed to improve customer experience while preventing common software malfunctions. Customers will be contacted by a Fresenius Kabi service representative or distributor to schedule a service appointment for upgrading the software. Customers with any questions or require additional information are instructed to contact the Fresenius Kabi Technical Hotline at (800) 937-5060.
Quantity in Commerce 7082 units
Distribution Worldwide distribution - US Nationwide and countries of Canada and China.
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 and Original Applicant = FRESENIUS KABI AG
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