MYLAB 70 X Vision and XVG, MYLAB TWICE and CLASS C (2018-01-22)
- Starting date:
- January 22, 2018
- Posting date:
- March 13, 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-66126
Affected products
- MYLAB 70 X VISION
- MYLAB 70 XVG
- MYLAB TWICE
- MYLAB CLASS C
Reason
Probes default settings in Elaxto Mode (Elastosonography Application) are found to be not appropriate for certain probes, resulting in overheating of the probe head.
Affected products
A. MYLAB 70 X VISION
Lot or serial number
Not applicable
Model or catalog number
9600169000
9806150000
Companies
- Manufacturer
-
Esaote S.P.A
Via Enrico Melen 77
Genova
16152
ITALY
B. MYLAB 70 XVG
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