Discovery IGS 7 OR & Innova IGS 5 (2021-04-22)
- Starting date:
- April 22, 2021
- Posting date:
- May 6, 2021
- 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-75529
Last updated:
2021-05-06
Affected Products
A. Discovery IGS 7 OR
B. Innova IGS 5
Reason
The IGS system can experience a single vertical linedefect where the vertical line divides and horizontallyshifts live monitor images into two unequal image partswithin the monitor display screen. This image offset issuecould potentially occur during a fluoroscopic acquisitionwhich could result in a delay of treatment.
Affected products
A. Discovery IGS 7 OR
Lot or serial number
D4-20-029
Model or catalog number
5774609
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE
B. Innova IGS 5
Lot or serial number
M2-20-054
M2-21-010
Model or catalog number
5771384
Companies
- Manufacturer
-
GE Medical Systems SCS
283 Rue De La Miniere
Buc
78530
FRANCE