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