The FDA has posted 7 enforcement recalls of infusion safety management software devices since 2025, including 4 Class I (most serious) recalls. Most recent report: Dec 31, 2025.
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes.…
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001).…
Certain Spectrum infusion pumps may have an incorrect version of software.
Certain Spectrum infusion pumps may have an incorrect version of software.
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to…
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Infusion Safety Management Software”). Informational only — verify against the FDA before acting.