FDA-Device2012-08-08Class I
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
Smiths Medical ASD, Inc.
Hazard
Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.
Sold states
Worldwide Distribution -- USA, including the state of CA, and country of Canada.
Affected count
607 pumps (257 USA, 350 Canada)
Manufactured in
1265 Grey Fox Rd, N/A, Saint Paul, MN, United States
Products
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2012Don't want to check this manually?
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