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Advantx and Innova System (2013-08-09)
- Starting date:
- August 9, 2013
- Posting date:
- September 19, 2013
- 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-35745
Recalled Products
A. Advantx LCA Angiographic System
B. Advantx LCLP+ BI Plane Cardiac System
C. Advantx LU-A Angiographic System
D. Innova 2000 Cardiovascular System
E. Innova IGS 540 Image Guided System
Reason
It was discovered that the four outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. This may increase the risk for fall of the monitor suspension.
Affected products
A. Advantx LCA Angiographic System
Lot or serial number
Not applicable
Model or catalog number
- S5800YB
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE
B. Advantx LCLP+ BI Plane Cardiac System
Lot or serial number
Not applicable
Model or catalog number
- S5800YF
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE
C. Advantx LU-A Angiographic System
Lot or serial number
Not applicable
Model or catalog number
- S5800A/AC
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE
D. Innova 2000 Cardiovascular System
Lot or serial number
Not applicable
Model or catalog number
- S1872LC
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE
E. Innova IGS 540 Image Guided System
Lot or serial number
Not applicable
Model or catalog number
- S18741AM
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE