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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
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…
- 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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