FDA Device recall Z-0863-2024
smiths medical Medfusion Model 3500 Syringe pump
- FDA Device
- Class I
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class I recall of smiths medical Medfusion Model 3500 Syringe pump by Smiths Medical Asd, citing 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 I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0863-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-19 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
smiths medical Medfusion Model 3500 Syringe pump
Reason
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.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0863-2024%22
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