Z-0863-2024Class I

smiths medical Medfusion Model 3500 Syringe pump

Name: Z-0863-2024 smiths medical Medfusion Model 3500 Syringe pump
Creator: Smiths Medical ASD Inc.
Published: 2023-12-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-12-19 / Open, Classified / root cause: software

FDA source

Smiths Medical ASD Inc. began a recall of smiths medical Medfusion Model 3500 Syringe pump on 2023-12-19. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0863-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-19
Posted: 2024-02-01
Recalling firm: Abbott Medical
Product: smiths medical Medfusion Model 3500 Syringe pump
Product code: FRN Pump, Infusion
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: Smiths Medical issued an URGENT MEDICAL DEVICE CORRRECTION notice to its consignees on 12/16/2023 by letter delivered via traceable means. The notice explained the issues with the pumps, the potential risks involved with their use, and requested the following actions be taken: 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. Please ensure you have the most recent Medfusion software installed on your pumps. 2. Complete and return the attached Response Form to [email protected] within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]. Inquires: To report adverse events or product complaints: Global Complaint Management, [email protected], 1-(866)-216-8806 Additional information or technical assistance: Technical Support, icumed.custhelp.com/app/market-action Questions about this Field Correction Notice: Field Corrections, icumed.custhelp.com/app/market-action
Quantity in commerce: 93177 pumps
Distribution: worldwide
Product codes and lots: All Medfusion Model 3500 pumps with software v3.X, v4.X, and v5.0.0 and was addressed in software v6.0.0 (2012) and all subsequent versions.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0863-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0863-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-02-01

Product code FRN

K040899Class IIMedex 3000 Series Mr Syringe Infusion PumpMedex, Inc. / cleared 2004-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)