Smiths Medical recalls Medfusion Syringe Pump Model 4000 with specific software versions (V1.5.0-V1.6.1) due to potential inaccurate delivery of medication after interrupted bolus or loading doses. Affected units may require software update or replacement.
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Smiths Medical is recalling Medfusion Syringe Pump Model 4000 with software versions V1.5.0 through V1.6.1. The issue could cause inaccurate medication delivery if a specific sequence of events occurs during use, potentially leading to incorrect dosing.
The software issue can cause inaccurate medication delivery if a specific sequence of events happens after an interrupted bolus or loading dose. This may lead to incorrect medication amounts being delivered to patients.
Healthcare professionals using Medfusion Syringe Pump Model 4000 with the listed software versions are most at risk. Patients receiving medication through these pumps could experience inaccurate dosing.
Check for the Medfusion Syringe Pump Model 4000 with serial numbers 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, or 4000-0106-231. The software versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 are also affected.
Review the software version on your Medfusion Syringe Pump Model 4000 to see if it is V1.5.0, V1.5.1, V1.6.0, or V1.6.1.
Contact Smiths Medical to update to a corrected software version if your pump is affected.
Software versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 are affected.
Contact Smiths Medical to update to a corrected software version or replace the pump if necessary.
Check for the Medfusion Syringe Pump Model 4000 with serial numbers 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, or 4000-0106-231.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2734-2020 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-2734-2020 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.
