CADD - Solis VIP Ambulatory Infusion Pump and Solis Ambulatory Infusion Pump
Brand(s)
Summary
Contact PHI PHAM QUANG at 514-905-2158 (PHI.PHAMQUANG@ICUMED.COM) or SHUI YEE KUAN at 514-905-2645
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
CADD - Solis VIP Ambulatory Infusion Pump |
Not applicable. |
Software A, C, E, F, v1.1.1, and v1.1.2 and was addressed in software v3.0.0 (2012) and all subsequent versions. |
CADD-Solis Ambulatory Infusion Pump - Main Unit |
Not applicable. |
Software A, C, E, F, v1.1.1, and v1.1.2 and was addressed in software v3.0.0 (2012) and all subsequent versions. |
Issue
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
Additional information
Details
Smiths Medical Asd, Inc.
6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442
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