Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported July 25, 2012
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.
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Sigma recalled SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage… - a low-severity action.
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage… was recalled by Sigma in July 25, 2012. Reason: Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum …. Check the official notice for the remedy. Verify recall #Z-2030-2012 with the FDA Devices before acting.
The recall
Sigma issued this low-severity FDA Devices recall-Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum ….
- Low
- severity level
- Class III
- classification
- July 25, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2030-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2030-2012) was formally reported on July 25, 2012, with the manufacturer initiating the action on April 23, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Sigma is listed as the recalling firm, operating out of Medina, NY. Federal records list the affected scope as 2,048 CD's.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,048 CD's
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2030-2012 |
| Date reported | July 25, 2012 |
| Date initiated | April 23, 2012 |
| Recalling firm | Sigma |
| Firm location | Medina, NY |
| Affected scope | 2,048 CD's |
| Distribution | Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2030-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sigma. Units affected: 2,048 CD's.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2012. Severity: Low. Recall number: Z-2030-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2030-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 25, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.