An FDA-recorded root-cause determination. The FDA lists 12 recalls with this root cause since 2025, 8 of them Class I (most serious). Most recent report: Jul 15, 2026.
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP an…
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP an…
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP an…
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz r…
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz r…
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.
Attachments may not mate with the tooth as intended in the digital treatment design.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.