Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0863-2024 — smiths medical Medfusion Model 3500 Syringe pump

U.S. FDA — Device Enforcement · United States · 2023-12-19 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0863-2024
Date of alert
2023-12-19
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Smiths Medical ASD Inc.
Product category
device
Product type
Devices
Reported risk: Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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