Health product recall

MYLAB70 XVISION and ULTRASOUND SYSTEM - Main Unit, MYLAB TWICE and MYLAB CLASS C (2018-01-03)

Starting date:
January 3, 2018
Posting date:
February 22, 2018
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-66030

Affected products

A. MYLAB70 XVISION SYSTEM - MAIN UNIT
B. MYLAB70 ULTRASOUND SYSTEM - MAIN UNIT
C. MYLAB TWICE
D. MYLAB CLASS C

Reason

When connected to the affected MYLAB Ultrasound Systems, the PA023E probe power monitoring settings may not be effective when Pulsed Wave Doppler is activated in specific operating conditions. This issue may result in the surface of the probe head overheating in around five minutes of continuous operations.

Affected products

A. MYLAB70 XVISION SYSTEM - MAIN UNIT

Lot or serial number

Not applicable

Model or catalog number

9806150000
9806150010
 

Companies
Manufacturer

Esaote S.P.A

Via Enrico Melen 77

Genova

16152

ITALY

B. MYLAB70 ULTRASOUND SYSTEM - MAIN UNIT

Lot or serial number

Not applicable

Model or catalog number

9806100000
9806100010

Companies
Manufacturer

Esaote S.P.A

Via Enrico Melen 77

Genova

16152

ITALY

C. MYLAB TWICE

Lot or serial number

Not applicable

Model or catalog number

101620000

Companies
Manufacturer

Esaote S.P.A

Via Enrico Melen 77

Genova

16152

ITALY

D. MYLAB CLASS C

Lot or serial number

Not applicable

Model or catalog number

101625000

Companies
Manufacturer

Esaote S.P.A

Via Enrico Melen 77

Genova

16152

ITALY