Product Wiki · Recalls · Health Canada — Medical Devices

Accu-Chek Spirit Combo Insulin Infusion Pump (2014-10-07) — recall 52190

Health Canada — Medical Devices · Canada · 2014-10-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
52190
Date of alert
2014-10-27
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Roche has received customer complaints related to defective capacitor where date and time setting were lost and power interruption, typically upon battery change, if the user does not set date and time correctly after restart of an affected pump as stated in the manual, the pump may deliver medication based on a time shifted basal profile.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/accu-chek-spirit-combo-insulin

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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