Product Wiki · Recalls · Health Canada — Medical Devices

PRISMAFLEX Hemodialysis Unit, PRISMAFLEX with Software release 4.00… — recall 60992

Health Canada — Medical Devices · Canada · 2018-06-01 · Type III

As described by Health Canada — Medical Devices: PRISMAFLEX Hemodialysis Unit, PRISMAFLEX with Software release 4.00, 5.00, 6.10, 7.10, 8.10 (2018-05-03)

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Agency
Health Canada — Medical Devices
Recall identifier
60992
Date of alert
2018-06-01
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Baxter corporation will be installing new firmware on all PRISMAFLEX Control Units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics, which may result in a "voltage out of range" malfunction alarm.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/prismaflex-hemodialysis-unit-p

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