Smiths Medical recalls Medfusion Model 4000 Syringe Infusion Pumps with software versions V1.6.0 or V1.6.1 that may delay sending infusion start messages to electronic health records, potentially affecting patient documentation and treatment programming.
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
Smiths Medical is recalling Medfusion Model 4000 Syringe Infusion Pumps with specific software versions (V1.6.0 or V1.6.1) that may delay sending infusion start messages to electronic health record systems. This could affect how treatments are programmed and documented for patients receiving fluids like blood, drugs, or antibiotics.
The software versions V1.6.0 and V1.6.1 have a feature called Smart Pump Programming (SPP) that may cause delays in sending infusion start messages to electronic health record systems. This could lead to issues with automatically programming treatments and documenting patient care in the system.
Healthcare professionals using Medfusion Model 4000 Syringe Infusion Pumps with software versions V1.6.0 or V1.6.1 for administering fluids to patients. Patients receiving treatments through these pumps may be at risk if documentation is delayed.
Check for the Medfusion Model 4000 Syringe Infusion Pump with software versions V1.6.0 or V1.6.1. The product has specific serial numbers and UDI codes listed in the recall notice. These pumps are used for precise fluid administration in clinical settings.
Look for the software version on the pump's display or in the device settings to confirm if it is V1.6.0 or V1.6.1.
The recall is for software versions V1.6.0 and V1.6.1 that may delay sending infusion start messages to electronic health record systems, potentially affecting treatment programming and documentation.
Check the software version on your pump. If it is V1.6.0 or V1.6.1, contact Smiths Medical for guidance on next steps.
The recall indicates a potential delay in documentation, but the risk is low as it does not involve immediate safety hazards like injury or death.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0272-2023 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0272-2023 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.
