| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01067-1 |
| Product Name/Description |
Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (MRI System)
ARTG Number: 223115 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
The epi2alt feature which is a type-in pulse sequence database (PSD) recently introduced in the DV25 software release that was intended to help a different brand users transitioning to GE scanners, contains a software issue in which images may be flipped and annotated incorrectly. This image orientation error will affect all axial, sagittal, and coronal diffusion-weighted echo planar imaging (EPI) scans using the ‘epi2alt’ type-in (PSD) in conjunction with the ‘FOCUS excitation’ option when the number of excitations (NEX) is set to larger than 1. No other PSDs or imaging options are affected by this issue. No injuries have been reported due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare recommends that users discontinue use of the type-in ‘epi2alt’ PSD option. Users may continue to use all diffusion-weighted EPI scans available through the user interface. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |