Smiths Medical ASD Inc. Recall 93754
Description: smiths medical Medfusion Model 3500 Syringe pump
Smiths Medical ASD Inc. Recall 93754 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0863-2024 |
| Event ID | 93754 |
| Event Description | smiths medical Medfusion Model 3500 Syringe pump |
| Product Type | Devices |
| Distribution | worldwide |
| Quantity | 93177 pumps |
| Recall 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. |
| Device Classification | 20240207 |
| Device 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. |
| Center Classification Date | 20240201 |
| Recall Initiation Date | 20231219 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | Letter |
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