Smiths Medical recalls Medfusion Model 4000 syringe pumps with specific software versions due to potential delivery errors and alarm issues. Affected units may require software updates to prevent incorrect medication administration.
Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). 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 installed on your pumps.
Smiths Medical is recalling Medfusion Model 4000 syringe pumps with certain software versions because they may cause incorrect medication delivery or alarms. This could lead to unsafe dosing if the software issues are not fixed.
The pumps may display incorrect medication doses or trigger alarms that don't properly address delivery issues. This could lead to unsafe medication administration if the software problems aren't corrected.
Healthcare professionals using Medfusion Model 4000 syringe pumps with specific software versions are most at risk. Patients receiving medication through these pumps could be affected if the software issues persist.
Check if your Medfusion Model 4000 syringe pump has software versions listed in the recall: v1.0.0, v1.1.0, v1.1.1, v1.1.2, v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4, v2.3, v2.4, v2.5, or any version before v1.6.5.
Identify your Medfusion Model 4000 syringe pump's software version to see if it's affected by the recall.
Ensure your pump has the most recent software update to fix the identified issues.
The recall addresses potential software issues that could cause incorrect medication delivery or alarms. Smiths Medical has corrected these issues in newer software versions.
No, the recall does not require immediate discontinuation. Users should check their software version and install the latest update if needed.
The recall states that Smiths Medical has corrected all issues in previous software updates. Ensure your pump has the most recent software installed.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0864-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0864-2024 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.
