Product Wiki · Recalls · Health Canada — Medical Devices

ALLURA XPER FD10/10, FD20/10, FD10, FD20 Main Units (2015-02-05) — recall 52775

Health Canada — Medical Devices · Canada · 2015-03-05 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
52775
Date of alert
2015-03-05
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Philips Healthcare has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with Health Canada safety code 20A and some provincial regulations. In certain circumstances, a software error can lead to a situation where the five minute Fluoroscopy Audible Signal does not sound, as required in Health Canada safety code 20A and some provincial regulations. No injuries attributed to the problem are reported.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/allura-xper-fd1010-fd2010-fd10

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