Official recall record

CADD - Solis VIP Ambulatory Infusion Pump and Solis Ambulatory Infusion Pump

Health Canada — Medical Devices · 2024-03-22 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2024-03-22
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

Smiths Medical identified legacy software anomalies which may occur in CADD-Solis and CADD-Solis VIP Ambulatory 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 reevaluating the patient risk, Smiths Medical determined that the issues identified were associated with sufficient patient risk that it is necessary to notify users, even if the remediation for an issue was available in previous software versions. Recall Start Date: March 1, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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