Health product recall

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

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

Sonolith i-sys System

Lot or serial number

SIS058

Model or catalog number

230793

Companies
Manufacturer

EDAP TMS France

4 Rue du Dauphiné, Parc d'Activité, La Poudrette-Lamartine

Vaulx-en-Velin

69120

FRANCE