Product Wiki · Recalls · Health Canada — Medical Devices

CADD - Solis VIP Ambulatory Infusion Pump and Solis Ambulatory… — recall 75243

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

As described by Health Canada — Medical Devices: CADD - Solis VIP Ambulatory Infusion Pump and Solis Ambulatory Infusion Pump

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
75243
Date of alert
2024-03-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cadd-solis-vip-ambulatory-infu

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