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SIGNA Pioneer
- Starting date:
- August 26, 2016
- 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-60252
Affected Products
SIGNA Pioneer
Reason
The following issue is being addressed by GE Healthcare file no. FMI 60903. Images may exhibit novel artifacts on magic T2 flair synthetic reconstructions that may be difficult to recognize without access to conventional T2 flair weighted images. This issue has the potential to lead to misinterpretation of the Magic Images when making medical diagnosis or treatment decisions. Magic Acquisition is unique in that all contrasts are acquired simultaneously, therefore any gross patient motion will impact all generated images and may further alter the presentation of the aforementioned novel artifacts. There have been no injuries reported as a result of this issue.
Affected products
SIGNA Pioneer
Lot or serial number
001719TA4
KZTBL1600023TJ
Model or catalog number
SIGNA PIONEER
Companies
- Manufacturer
-
GE Healthcare Japan Corporation
7-127 Asahigaoka, 4 Chome, Hinoshi
Tokyo
191-8503
JAPAN