Z-0989-2017Class II

i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device...

Name: Z-0989-2017 i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device...
Creator: Health Robotics S.r.l.
Published: 2016-11-23
License: https://open.fda.gov/license/

Omnicell, Inc. / initiated 2016-11-23 / Terminated / root cause: software

FDA source

HEALTH ROBOTICS S.R.L. began a recall of i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448 on 2016-11-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0989-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-23
Posted: 2017-01-10
Terminated: 2017-03-15
Recalling firm: Omnicell, Inc.
Product: i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Product code: NEP System/Device, Pharmacy Compounding
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: All serial numbers are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0989-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0989-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-10

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)