| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00675-1 |
| Product Name/Description |
MR ACGD Cabinet FRU X Gradient Cable used with GE MRI System
Affected Systems:
Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi.
ARTG Number: 223115 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation. Incorrect information taken from study images could result in inappropriate treatment decisions, but should be obvious to the operator. Injury or impairment might result if undetected. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE is advising hospitals that a geometry check will identify if the issue is occurring. A GE Healthcare representative will contact the customer to arrange an appointment to correct the affected device. This action has been closed-out on 15/08/2016. |
| Contact Information |
1800 659 465 - National Call Centre |