Lower risk Medical device recall · FDA · Published December 19, 2023

Smiths Medical Medfusion 4000 Syringe Pump Software Issues Recall

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0864-2024Medical device Smiths Medical ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/56534-smiths-medical-medfusion-4000-syringe-pump-software-issues-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/56534-smiths-medical-medfusion-4000-syringe-pump-software-issues-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0864-2024

Cite this page

“Smiths Medical Medfusion 4000 Syringe Pump Software Issues Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56534-smiths-medical-medfusion-4000-syringe-pump-software-issues-recall. Based on FDA recall #Z-0864-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0864-2024%22&limit=1).

The FDA announced on December 19, 2023, that Smiths Medical ASD Inc. is recalling its Medfusion Model 4000 syringe pumps due to potential software issues. Owners should ensure they have the most recent Medfusion software installed on their pumps.

How to tell if you have it

Smiths Medical Medfusion Model 4000 syringe pump
Software versions: v1.0.0, v1.1.0, v1.1.1, v1.1.2, v1.5.0, v1.5.1, 1.6.0, v1.6.1, v1.6.4, v2.3, v2.4, v2.5
All versions prior to v1.6.5

The hazard

According to the FDA, the affected pumps may experience issues including delivery during motor not running high priority alarms, re-administered loading doses, incorrect critical data failure alarms, interruption of bolus or loading dose delivery, and incorrect total bolus/loading dose displays. Other reported hazards include volume limits before bolus/loading dose complete, incorrect drug library lower limit display, depleted battery alarms, loss of wireless connectivity, and PharmGuard server password issues.

Context

GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since 2017-06-05. Recent similar recalls include the Smiths Medical CADD Solis VIP Infusion Pump Recall for potential thermal damage (2025-04-10) and false alarm risk (2025-04-10), as well as the Smiths Medical CADD Solis HSPCA Pump recall for wireless connection alarms (2025-04-10). Other recent recalls of similar products include the Baxter Novum IQ Syringe Pump Recall for software issues (2026-08-11), the ICU Medical Plum Duo IV Pump Recall for risk of incorrect drug delivery (2026-04-29), and the Medtronic SynchroMed Flex Infusion Software Issue recall (2026-04-08).

How to tell if you have this one

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.

Brand
Smiths Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify your Medfusion Model 4000 syringe pump's software version to see if it's affected by the recall.
Install Latest Software
Ensure your pump has the most recent software update to fix the identified issues.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore, Saudi Arabia, Lebanon, and Malaysia” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 50 days after the firm started it.

Dec 19, 2023Firm started the recall
Feb 1, 2024FDA classified it Class I
Feb 7, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Smiths Medical recalls

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Keep exploring

More Smiths Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/56534-smiths-medical-medfusion-4000-syringe-pump-software-issues-recall">Smiths Medical Medfusion 4000 Syringe Pump Software Issues Recall (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0864-2024 (December 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0864-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.