Smiths Medical recalls Medfusion Model 3500 syringe pumps with software versions v3.x, v4.x, or v5.0.0 due to potential incorrect dosing and infusion errors. Ensure software v6.0.0 or later is installed.
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.
Smiths Medical is recalling Medfusion Model 3500 syringe pumps with software versions before v6.0.0. These pumps may deliver incorrect doses or stop infusions unexpectedly, which could lead to unsafe medication administration.
Older software versions (v3.x, v4.x, v5.0.0) may cause the pump to deliver incorrect medication doses, restart infusions with wrong settings, or stop delivering critical doses. These issues could lead to unsafe medication administration if the pump is not updated to software v6.0.0 or later.
Healthcare professionals using Medfusion Model 3500 syringe pumps with software versions v3.x, v4.x, or v5.0.0 are most at risk. Patients receiving medication through these pumps could experience incorrect dosing if the software is outdated.
Check if your Medfusion Model 3500 syringe pump has software versions v3.x, v4.x, or v5.0.0. These pumps were sold between 2012 and 2013 and were addressed in software updates starting v6.0.0.
Install the latest Medfusion software version (v6.0.0 or later) to fix the issues.
Older software versions (v3.x, v4.x, v5.0.0) may cause incorrect dosing or infusion errors. These issues were fixed in software updates starting v6.0.0.
No, but you must update to software v6.0.0 or later to ensure safe operation.
Check your pump's software version in the device settings menu. Versions v3.x, v4.x, or v5.0.0 are affected.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0863-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0863-2024 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
