LifeShield Infusion Safety Software Suite - LifeShield DLM 2.1Recalls & reported problems
Icu Medical, Inc. · Infusion Safety Management Software · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- May 2, 2025Class IIOpen, Classified
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 patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
Z-1763-2025 · Root cause: Software Design Change · Recall details · FDA record ↗
Other Infusion safety management software devices
- SIGMA Spectrum Infusion Pump 35700BAX2Baxter Healthcare Corporation · Infusion safety management software9 recalls12 deaths11,585 reports
- Spectrum IQ 3570009Baxter Healthcare Corporation · Infusion safety management software11 recalls10 deaths9,086 reports
- Alaris 8975Carefusion 303, Inc. · Infusion safety management software169 reports
- LifeShield Infusion Safety Software Suite 17003-02ICU Medical, Inc. · Infusion safety management software2 recalls0 reports
- Alaris 9601Carefusion 303, Inc. · Infusion safety management software2 recalls0 reports
- BD Alaris™ Infusion Adapter, Software Not ApplicableCarefusion 303, Inc. · Infusion safety management software1 recall0 reports
- BD Intelliport 516704Becton, Dickinson And Company · Infusion safety management software28 reports
- Ivenix Infusion System 030-0027-06Fresenius Kabi AG · Infusion Safety Management Software3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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