Smiths Medical Medfusion 4000 Syringe Pump Software Defects Recall
The FDA is recalling Smiths Medical Medfusion Model 4000 syringe pumps due to software defects affecting medication delivery, alarms, and display accuracy. Users should install the latest software version to correct these issues.
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: This is an FDA Class I recall for a medical device, which requires a minimum severity score of 4. Although no illnesses or injuries have been reported and the defects have been corrected in software updates, the Class I designation reflects the potential for serious patient harm from incorrect medication delivery.
Plain-English summary
The FDA is recalling the Smiths Medical Medfusion Model 4000 syringe pump due to multiple software defects that could affect the safe delivery of medication.
The affected units contain software versions prior to v1.6.5, as well as specific versions v2.3, v2.4, and v2.5. The software defects include issues with alarm function, dosage display accuracy, medication delivery timing and amount, wireless connectivity, and other related functions. These defects could result in patients receiving incorrect medication amounts or at incorrect times, or failing to be alerted to pump malfunction.
The recall affects 60,146 Medfusion Model 4000 pumps distributed to users in the United States, Canada, Great Britain, Bermuda, Australia, Germany, Singapore, Saudi Arabia, Lebanon, and Malaysia.
Smiths Medical has corrected all issues identified in this recall through software updates released prior to this notification, with corrections carried forward into all subsequent software versions. Healthcare providers and users should ensure they have installed the most recent Medfusion Model 4000 software on their pumps. For software update instructions and additional information, contact Smiths Medical ASD Inc. or visit the FDA's recall information at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-0864-2024.
The recalled product
- Product
- smiths medical Medfusion Model 4000 syringe pump
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Syringe Pump
- Affected units
- 60,146
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 (13)
- All Medfusion Model 4000 with software versions: v1.0.0
- v1.1.0
- v1.1.1
- v1.1.2
- v1.5.0
- v1.5.1
- 1.6.0
- v1.6.1
- v1.6.4
- v2.3
- v2.4
- v2.5
- and all versions prior to v1.6.5.
Distribution
Distributed nationwide across the United States.
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