ACUSON ULTRASOUND SYSTEMS (2015-07-02)

Starting date:

July 2, 2015

Posting date:

July 21, 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-54304

• Reason
• Affected products

Affected Products

1. ACUSON S2000
2. ACUSON S3000

Reason

Use of the software tool virtual touch tissue imaging quantification (VTIQ) on the ACUSON S2000 and ACUSON S3000 systems has a potential measurement error. Specifically, the color mapping is misaligned with the B-mode image underneath. What this results in for the user is a difference between the color mapping and the shear wave velocity readout. The velocity result in m/s does not correspond with the velocity color scale. When repositioning the (VTIQ) region of interest from the original location to a new one, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data.

Affected products