ILUMA Adverse Event — Malfunction (MDR MW5005578)
ILUMA Adverse Event — Malfunction (MDR MW5005578) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ILUMA; Generic name: COMPUTED TOMOGRAPHY X-RAY SYSTEM CONE BEAM CT SYSTEM; Manufacturer: IMTEC CORPORATION.
| Device | ILUMA |
|---|---|
| Generic name | COMPUTED TOMOGRAPHY X-RAY SYSTEM CONE BEAM CT SYSTEM |
| Manufacturer | IMTEC CORPORATION |
| Report number | MW5005578 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Narrative | POTENTIAL PRODUCT PROBLEM. THE IMTEC CORP. ILUMA CONE BEAM CT SCANNER EMITS X-RAYS DURING A RAMP-UP PERIOD OF EIGHT SECONDS BEFORE IMAGE ACQUISITION BEGINS. A PT, THEREFORE, WOULD BE EXPOSED TO 8 SECONDS OF RADIATION BEFORE ANY USEFUL IMAGING BEGINS. THE VENDOR WAS NOTIFIED AND ACKNOWLEDGES THE PROBLEM, AND IS PLANNING TO RETROFIT THE SYSTEMS WITH A SHUTTER MECHANISM TO SHIELD X-RAYS DURING THE RA |
| Source | openFDA MAUDE (device adverse events) |
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