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Smiths Medical ASD Inc. is recalling Medfusion model 3500 syringe pump due to issues associated with earlier software versions (before v.6) of the medical pump. Issues associated with earlier software versions of the medical pump include high-priority alarms during motor issues, wrong infusion restarts, screen locks, bolus interruptions, incorrect dose displays, low doses, motor errors, wrong settings recall, corrupt configurations, auto locks, and toolbox issues with loading dose time values.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal.
Questions?
If you have questions about this recall, contact Smiths Medical at 1-(866)-216-8806.
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