Recall Z-0107-2019 ยท PHC Infusion Safety Management Software
Baxter Healthcare Corporation
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
| Date | Sep 18, 2018 |
| Status | Terminated |
| Reason | If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion. |
| Root cause | Software design |
| Action | The firm initiated their field correction by email on 09/14/2018. The notice alerted the consignee of the problem and stated that Baxter would be issuing a software update to correct the issue. |
| Quantity | 354 units |
| Distribution | NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software Baxter Healthcare Corporation, May 11, 2018 |