Smiths Medical recalls Medfusion Syringe Pumps with specific models and software versions due to potential force sensor calibration drift causing false alarms or delayed occlusion detection.
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 certain Medfusion Syringe Pumps (models 3500-0600-00 through 3500-0600-249) because a force sensor may drift out of calibration. This could lead to false alarms or delayed detection of blockages, which might cause treatment issues for patients using 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 the pump to either delay detecting blockages or trigger false alarms, potentially leading to treatment complications.
Healthcare professionals using the Medfusion Syringe Pump for medical treatments are most at risk, particularly those with specific model numbers and software versions listed in the recall.
Check if your Medfusion Syringe Pump has model numbers 0600-00, 0600-01, 0600-50, 0600-51, 0600-82, or 0600-249, or software versions v3 through v6. The recall covers all units with these specific model numbers and serial numbers.
Identify your Medfusion Syringe Pump's model number and software version to see if it matches the recalled models (0600-00 through 0600-249) or software versions v3 through v6.
Reach out to Smiths Medical for further guidance on the recall and potential remedies if your pump is affected.
Smiths Medical is recalling these pumps due to a potential force sensor calibration drift that could cause false occlusion alarms or delayed detection of blockages, especially in pumps made before April 2022.
No, the recall does not require immediate discontinuation. Users should check their pump model and software version to determine if it is affected and contact Smiths Medical for further instructions.
Software versions v3 through v6 are affected, along with the specific model numbers listed in the recall.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0078-2024 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0078-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
