Recall Z-2095-2025 ยท PHC Infusion Safety Management Software
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
| Date | Jul 17, 2025 (initiated Jun 20, 2025) |
| Status | Open, Classified |
| Reason | Certain Spectrum infusion pumps may have an incorrect version of software. |
| Root cause | Employee error |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 6/20/25 was sent to customers. Actions to be Taken by Customers 1. Immediately locate Spectrum pumps with the affected serial numbers and remove them from service. The product code and serial number can be found on the bottom of the infusion pump. 2. Check and record the software version installed on the pump. The software on a V6 pump should begin with the number 6 and the software on a V8 pump should begin with the number 8. The software version is located on the startup screen upon powering up the pump as pictured on the next page. |
| Quantity | 14 units |
| Distribution | US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133801 | BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY Baxter Healthcare Corporation, May 7, 2014 |