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Medfusion 3500 syringe infusion pumps
Official notice
23 Nov 2023
Last checked
23 Nov 2023
An official Health Canada notice concerns Medfusion 3500 syringe infusion pumps. Smiths Medical identified legacy software anomalies which may occur in the Medfusion 3500 syringe infusion pumps. The legacy software anomalies were identified during a historical review of the risk evaluations conducted during the software development process. The historical review determined that some of the risk evaluations conducted in the past did not fully account for all the risks associated with the issues. After re-evaluating the patient risk, Smiths Medical determined that the issues identified were associated with sufficient patient risk that it is necessary to notify users and apply to pump versions before v5.0.0. Recall start date: November 7, 2023 Published 2023-11-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74634
Official notice
2023-11-23
The hazard
The hazard
Smiths Medical identified legacy software anomalies which may occur in the Medfusion 3500 syringe infusion pumps. The legacy software anomalies were identified during a historical review of the risk evaluations conducted during the software development process. The historical review determined that some of the risk evaluations conducted in the past did not fully account for all the risks associated with the issues. After re-evaluating the patient risk, Smiths Medical determined that the issues identified were associated with sufficient patient risk that it is necessary to notify users and apply to pump versions before v5.0.0. Recall start date: November 7, 2023
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Smiths Medical Asd, Medfusion 3500 Syringe Infusion Pumps.
Source & status
Source & status
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Tier
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Classification
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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