Trust Digital In-The-Ear Hearing Aid System (2019-09-18)
- Starting date:
- September 18, 2019
- Posting date:
- January 10, 2020
- 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-72067
Last updated: 2020-01-10
Affected Products
- Trust Digital In-The-Ear Hearing Aid
- Linx 3d
- Trust
- Enzo 3d
- Forte
- Linx Quattro Receiver In-The-Ear (RIE)
- Vida In-The-Canal (ITC)
- Vida In-The-Ear (ITE)
- Vida Mini Receiver In-The-Ear (RIE)
- Vida Invisible-In-The-Canal (IIC)
Reason
A software bug in the service & repair tool affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users' residual hearing at risk of experiencing unintended additional available gain to varying degrees of 18db flat linear gain or potentially in worst case full on gain.
Affected products
-
Trust Digital In-The-Ear Hearing Aid
Lot or serial number
- 1827008532
- 1903050825
- 1927005064
Model or catalog number
- TST6CIC-MP
- TST9MIH-S-HP
- TST9MIH-S-LP
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA
B. Linx 3d
Lot or serial number
1827009445
1827007020
1827007021
1927004522
1826735309
1826848043
1826848044
1849082965
1856143491
1856143492
1856802112
1866077234
1886022379
1886280547
1949080826
Model or catalog number
LT7IIC-LP
LT7ITE-DW-HP
LT9ITC-DW-MP
LT761-DRW
LT762-DRW
LT961-DRWZ
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA
C. Trust
Lot or serial number
1756813503
1856457814
1949026731
1927000076
1927003268
1927005317
Model or catalog number
TST963-DRW
TST17ITE-DW-UP
TST6ITC-W-HP
TST6MIH-W-UP
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA
D. Enzo 3d
Lot or serial number
1949050068
Model or catalog number
ET598-DW
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA
E. Forte
Lot or serial number
1826690709
1826696443
1826738783
1926018832
1827003158
Model or catalog number
FT861-DRW
FT862-DRW
FT8MIH-W-UP
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA
F. Linx Quattro Receiver In-The-Ear (RIE)
Lot or serial number
1886167780
Model or catalog number
RE762-DRW
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA
G. Vida In-The-Canal (ITC)
Lot or serial number
1827009752
1927005424
Model or catalog number
VA8ITC-DW-HP
VA8ITC-W-UP
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA
H. Vida In-The-Ear (ITE)
Lot or serial number
1927004931
1927004989
Model or catalog number
VA8ITE-DW-UP
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA
I. Vida Mini Receiver In-The-Ear (RIE)
Lot or serial number
1886320597
Model or catalog number
VA861-DRWZ
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA
J. Vida Invisible-In-The-Canal (IIC)
Lot or serial number
1927004032
Model or catalog number
VA8IIC-LP
Companies
- Manufacturer
-
GN RESOUND CANADA ATA RESOUND CANADA ATA RESOUND GN
2 East Beaver Creek Road, Building 3
Richmond Hill
L4B 2N3
Ontario
CANADA