Recall Z-1124-2012 ยท IZI System, X-Ray, Angiographic
GE Healthcare, LLC
GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.
| Date | Mar 19, 2012 (initiated May 4, 2011) |
| Status | Terminated |
| Reason | It was discovered that when the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and enabled on the Diamentor M4-KDK which is not certified as required by FDA regulation (Subpart J). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare will alert affected Innova users with a Diamentor M4-KDK unit of this issue and the workaround to mitigate this issue. GE Healthcare will bring affected Innova units in the field into compliance by enabling the Innova certified display and providing affected customers with an Operators Manual Addendum and Service Manual Addendum which will address this topic. GE Healthcare will correct all affected systems by updating the system's Operator and Service Correction manuals and enabling the innova dose display on the Live and Reference monitors and the DLconsole. The Diamentor M4-KD |
| Quantity | 19 |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.