Product Wiki · Recalls · Health Canada — Medical Devices

Instatrak 3500 Plus System — recall 49315

Health Canada — Medical Devices · Canada · 2012-12-24 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
49315
Date of alert
2012-12-24
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: The reason the recall was intiated was because several potential safety issues have been identified with the use of the device. The navigation system may lock up or restart unexpectedly. If two scans from the same modality and same patient are transferred to the system, they may combine into one scan, and the transmitter arm movement after registration may result in inaccuracy and users may experience difficulty calibrating the device.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/instatrak-3500-plus-system

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.