Smiths Medical MD, Inc., Class II Medfusion 3500

Company:Smiths Medical MD, Inc., .
Date of Enforcement Report:5/2/2007

Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4, Recall # Z-0768-2007

Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump’s startup sequence when the pump’s Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.

Model 3500 pump with 4.1.4 or 4.1.3 software.

Recalling Firm: Smiths Medical MD, Inc., Saint Paul, MN, by a ‘Customer Information Bulletin’ dated February 3, 2007 and a ‘Product Recall Notification’ dated February 16, 2007.
Manufacturer: Medex Inc, Duluth, GA. Firm initiated recall is ongoing.

23,519 units

Nationwide, Canada and Italy

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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