Sonolith i-sys System (2019-01-17)

Starting date:

January 17, 2019

Posting date:

March 8, 2019

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-69228

• 
  Reason
• 
  Affected products

Affected Products

Sonolith i-sys System

Reason

In case of rupture of the monitor arm fixing element, the system tilts laterally on a height of about 500 mm but remains retained to its support. The arm geometry does not allow a suspension above the patient and therefore, this incident can only affect the operator resulting in benign injury, possibly requiring a medical procedure.

Affected products