SIGMASpectrum Infusion Pump Master Drug Library — Class III medical device recall Z-2030-2012
Terminated recall by Sigma, reported 2012-07-25, distributed nationwide. Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum I
| Recall number | Z-2030-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sigma, Medina, NY, United States |
| Recall initiated | 2012-04-23 |
| Classified | 2012-07-18 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2018-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,048 cd |
| Reason classes | software |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2030-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.