FDA Medical Device Recalls (openFDA)
HEALTH ROBOTICS S.R.L.: i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
- Recall number
- Z-0989-2017
- Recalling firm
- HEALTH ROBOTICS S.R.L.
- Product
- i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
- Status
- Terminated
- Initiated
- 2016-11-23
- Posted
- 2017-01-10
- Terminated
- 2017-03-15
- Reason
- 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
- 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
- 121 systems
- Distribution
- Shipped throughout United States.
- Lot, serial or model codes
- All serial numbers are affected.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEP
- Firm FEI
- 3006153342
- Firm city
- Bolzano
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28