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Health Canada Medical devices

Prismax Control Unit

Issued March 29, 2022
Issue
Baxter Corporation is issuing a correction for the Prismax. If the operator initiates therapy by entering a value other than the default value for the patient gain/loss limit or the return pressure drop limit and uses the same patient function, the Prismax system will return the patient gain/loss limit or the return pressure drop limit to the default value, rather than the non-default value entered at the initiation of treatment. Recall start date: Mar 17, 2022
Hazard description
Inaccurate test or measurement results
Product
Product name
Prismax Control Unit
Reference
ID
RA-64030