Smiths Medical recalls Medfusion Syringe Pump models 4000-XXXX-XX with serial numbers 0100-50 through 0107-01. A force sensor calibration issue may cause false alarms or delayed occlusion detection, requiring users to check software versions v3-v6.
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.
Smiths Medical is recalling Medfusion Syringe Pump models 4000-XXXX-XX with specific serial numbers and software versions v3-v6. The recall is due to a potential force sensor calibration shift that could cause false alarms or delayed detection of blockages in the pump.
The force sensor in the occlusion detector may drift out of calibration over time, especially in pumps made before April 2022. This can cause false occlusion alarms or delay detection of blockages, potentially leading to unsafe treatment conditions.
Healthcare professionals using the Medfusion Syringe Pump for medical treatments are most at risk, particularly those with devices produced before April 2022.
Check if your pump has serial numbers starting with 0100-50 through 0107-01 and software versions v3, v4, v5, or v6. Devices produced before April 2022 are at higher risk.
Identify your pump's serial number to see if it matches the recalled range (0100-50 through 0107-01).
Confirm your pump's software version is v3, v4, v5, or v6 to determine if it's affected.
The force sensor calibration may drift, causing false occlusion alarms or delayed detection of blockages, especially in pumps made before April 2022.
Check your pump's serial number and software version. If affected, contact Smiths Medical for guidance on next steps.
No, only specific models with serial numbers 0100-50 through 0107-01 and software versions v3-v6 are affected.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0079-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0079-2024 from Smiths Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
