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Innova IGS 520 and IGS-540 Image Guided Systems (2013-08-09)
- Starting date:
- August 9, 2013
- Posting date:
- February 3, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals
- Identification number:
- RA-37549
Recalled Products
- Innova IGS 540 Image Guided System - Main Unit
- Innova IGS 520 Image Guided System - Main Unit
Reason
The Innova system can unexpectedly stop delivering X-Rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue. The loss of the fluoro imaging capability of an interventional C-Arm X-Ray imaging unit may cause substantial harm to a patient, in case it happens during a "sensitive phase" of a coronary intervention.
Affected products
A. Innova IGS 540 Image Guided System - Main Unit
Lot or serial number
Not Applicable
Model or catalog number
2335129
2335129-5
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE
B. Innova IGS 520 Image Guided System - Main Unit
Lot or serial number
Not Applicable
Model or catalog number
2335129-4
2335139-X
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE