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Various Sorin Group Italia Cardiac Therapy Devices (2017-04-11)
- Starting date:
- April 11, 2017
- Posting date:
- May 2, 2017
- 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-63142
Affected Products
- Ovatio VR ICD 6250
- Ovatio DR ICD 6550
- Ovatio CRT-D 6750
- Paradym CRT-D 8750
- Paradym SONR CRT-D Phd 8770
- Paradym DR LCD 8550
- Paradym VR LCD 8250
- Paradym RF VR LCD 9250
- Paradym RF DR LCD 9550
- Paradym RF CRT-D 9750
- Paradym RF SONR CRT-D 9770
- Intensia DR LCD 154
Reason
Livanova is notifying physicians of the possibility of undetectable battery depletion in the event of recurrent shock capacitor charging and what actions to take to mitigate risks associated with the issue.
Affected products
A. Ovatio VR ICD 6250
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
6250
Companies
- Manufacturer
-
Sorin Group Italia S.R.L. (Sorin CRM)
Via Crescentino S.N.
Saluggia, Vercelli
13040
ITALY
B. Ovatio DR ICD 6550
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
6550
Companies
- Manufacturer
-
Sorin Group Italia S.R.L. (Sorin CRM)
Via Crescentino S.N.
Saluggia, Vercelli
13040
ITALY
C. Ovatio CRT-D 6750
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
6750
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
D. Paradym CRT-D 8750
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
8750
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
E. Paradym SONR CRT-D Phd 8770
Lot or serial number
015YI081
019YI02F
019YI034
933YI050
Model or catalog number
8770
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
F. Paradym DR LCD 8550
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
8550
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
G. Paradym VR LCD 8250
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
G. Paradym VR LCD 8250
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
8250
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
H. Paradym RF VR LCD 9250
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
9250
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
I. Paradym RF DR LCD 9550
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
9550
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
J. Paradym RF CRT-D 9750
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
9750
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
K. Paradym RF SONR CRT-D 9770
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
9770
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY
L. Intensia DR LCD 154
Lot or serial number
446AE033
448AE007
449AE042
502AE011
502AE09E
Model or catalog number
154
Companies
- Manufacturer
-
Sorin Group Italia S.R.L.
Via Crescentino, SN,
Saluggia, Vercelli,
13040
ITALY