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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 067 06 18 000 |
| Date submitted: |
6/17/2018 |
| Manufacturer: | GE Healthcare |
| Device Type: | TwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant. |
| Description: | GE Healthcare MRI systems Software Version |
| Medical Device Identifier: | This correction applies to some units of the following GE Healthcare MRI system types: TwinSpeed, Signa Infinity, Excite, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Excite HD 1.5T, Signa Excite HD 3.0T, 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant. |
| Reason of Field Safety Corrective Action: | It has come to our attention that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. If the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch. |
| Remedy Action: | GE Healthcare will inspect all affected systems and ensure the proper software version is installed. This will be performed at no cost to you. GE Healthcare will check systems remotely (on-line) where possible, and will visit your site if a remote check is not possible.
GE Healthcare will advise you after your software version has been inspected and inform you if any correction is needed. If a correction is needed, a service representative will contact you to arrange for this correction.
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| Athorized Representative/Importer/Distributor: | GE Healthcare |
| Report Source: | NCMDR |
| Source Ref. Number: | 261CF65FA0237 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: | S(2jvfssw5mnvw2rsjjlq2wwm2))/App_Themes/WhiteTheme/images/icons/btn_pdf.gif) GE Healthcare - MRI.pdf |
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