Smiths Medical Medfusion 4000 Syringe Infusion Pump Software Recall
Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps due to a software anomaly that causes device history log corruption and triggers a Watchdog Fail-Safe alarm.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The source text describes a software anomaly causing the device to cease operation and alarm, but does not report any injuries, illnesses, or deaths.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the Medfusion 4000 Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1. The recall involves 607 pumps, with 257 units distributed in the USA and 350 units in Canada. The affected devices are identified by specific reorder numbers and serial codes listed in the official recall notice.
The recall is due to a software anomaly that causes device history log corruption and triggers a Watchdog Fail-Safe alarm. When this failure mode occurs, the device ceases operation and visual and audible alarms sound. The pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
Healthcare facilities and consumers with these specific pumps should stop using them and contact Smiths Medical for instructions on how to proceed with the recall.
The recalled product
- Product
- 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
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Infusion Pump
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- and 2004550.
Distribution
Distributed in 1 state:
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