Product Wiki · Recalls · Health Canada — Medical Devices

Spectrum Infusion Pump (V8.00.02) — recall 56138

Health Canada — Medical Devices · Canada · 2017-02-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56138
Date of alert
2017-02-14
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: Software V8.00.02 contains an anomaly that may cause a "sharp watchdog timeout" error message when a message is being written to the pump's event history log, and the length of that message exactly matches the size of the available memory at the end of a memory sector. The software anomaly may result in a delay or interruption in therapy while an alternative pump is obtained.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/spectrum-infusion-pump-v80002

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