Product Wiki · Recalls · Health Canada — Medical Devices

Auto 2D Quantification Software, Auto Cardiac Motion QUantification… — recall 52871

Health Canada — Medical Devices · Canada · 2014-11-26 · Type II

As described by Health Canada — Medical Devices: Auto 2D Quantification Software, Auto Cardiac Motion QUantification software and Q-Station (2014-11-06)

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Agency
Health Canada — Medical Devices
Recall identifier
52871
Date of alert
2014-11-26
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: Philips has become aware that when using the QLAB Auto 2D Quantification (A2DQ) and Auto Cardiac Motion Quantification (ACMQ) applications to calculate End-Systolic Volume (ESV), the reported ESV may be smaller ESV calculated by manual tracing without the use of QLAB. Correspondingly, the left ventricular Ejection Fraction (EF) calculated using these applications may be higher than the EF calculated by manual tracing without the use of QLAB. Philips' investigation has found that this difference may occur in cases where the EF is less than approximately 40%.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/auto-2d-quantification-softwar

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