Auto 2D and Cardic Motion Quantification Softwares (2015-04-14)

Starting date:

April 14, 2015

Posting date:

May 1, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-53217

• Reason
• Affected products

Recalled Products

A. AUTO 2D QUANTIFICATION SOFTWARE
B. AUTO CARDIAC MOTION QUANTIFICATION SOFTWARE

Reason

Philips has become aware that when using the QLAB 10.0 Auto 2d Quantification (a2DQ) and Auto Cardiac Motion Quantification (ACMQ) applications to calculate end-systolic volume (ESV), the reported ESV may be smaller than the 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. Philips' investigation has found that these differences may occur in cases where the EF is less than approximately 40%.

Affected products