ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM (2021-02-16)

Starting date:

February 16, 2021

Posting date:

February 26, 2021

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-75053

Last updated:
2021-02-26

• 
  Reason
• 
  Affected products

Affected Products 

ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM

Reason

VA11A software for ACUSON Sequoia

The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation.This may result in an incorrect EDD. An incorrect EDD may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births.

Affected products