Product Wiki · Recalls · Health Canada — Medical Devices

ALLURA XPER FD 10 AND FD 20 SYSTEMS (2016-02-18) — recall 54885

Health Canada — Medical Devices · Canada · 2016-03-04 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
54885
Date of alert
2016-03-04
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 has discovered through customer complaints and internal testing that uncontrolled geometry movements can occur when the system is not switched on/off regularly. Due to the nature of the problem the user will perceive a gradually increased sluggishness. Upon activation of the IU controls an uncontrolled geometry movement can occur. The uncontrolled movements are immediately stopped upon release of the IU controls.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/allura-xper-fd-10-and-fd-20-sy

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