FDA Device recall Z-0077-2024
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 by Smiths Medical Asd, citing A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the for….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0077-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-16 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
Product
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
Reason
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
Identifiers
| code_info | UDI/DI 10610586032325, All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0077-2024%22
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