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U.S. Department of Health and Human Services

Class 2 Device Recall i.v. Station, i.v. Station ONCO

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  Class 2 Device Recall i.v. Station, i.v. Station ONCO see related information
Date Initiated by Firm November 23, 2016
Date Posted January 10, 2017
Recall Status1 Terminated 3 on March 15, 2017
Recall Number Z-0989-2017
Recall Event ID 76102
Product Classification System/device, pharmacy compounding - Product Code NEP
Product i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System
Device Listing Number E454448
Code Information All serial numbers are affected.
Recalling Firm/
Manufacturer		 HEALTH ROBOTICS S.R.L.
Via Sebastian Altmann 9 A
39100
Bolzano Italy
Manufacturer Reason
for Recall		 The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.
FDA Determined
Cause 2		 Software design
Action Omincell mailed an Urgent Medical Device Field Correction Notification letter to affected customers on 11/21/2016. The letter provided information of the event and instructions on how to continue operating the device to prevent risks. The issue will be corrected with a software update.
Quantity in Commerce 121 systems
Distribution Shipped throughout United States.
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.
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