FDA Device recall Z-2030-2012
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software
- FDA Device
- Class III
- terminated
- Published 2012-07-25
On 2012-07-25 the FDA classified a Class III recall of SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software by Sigma, citing sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2030-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-04-23 |
| Published | 2012-07-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Sigma |
| Distribution | US |
Product
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Reason
Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.
Identifiers
| code_info | All versions |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2030-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.