Recall Z-0989-2017 ยท NEP System/Device, Pharmacy Compounding
HEALTH ROBOTICS S.R.L.
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
| Date | Jan 10, 2017 (initiated Nov 23, 2016) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.