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9900 Adverse Event — Malfunction (MDR 1720753-2008-16328)

9900 Adverse Event — Malfunction (MDR 1720753-2008-16328) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 9900; Generic name: FLUOROSCOPIC X-RAY; Manufacturer: GE OEC MEDICAL SYSTEMS, INC.

Device9900
Generic nameFLUOROSCOPIC X-RAY
ManufacturerGE OEC MEDICAL SYSTEMS, INC
Report number1720753-2008-16328
Event typeMalfunction
Product problemY
Date received2008-02-21
Report sourceHealth Professional, User facility
NarrativeIT WAS REPORTED THAT THE IRIS CLOSED DOWN ON THE 9900 SYS. IT WAS ALSO NOTED THAT THE SYS PRESENTED A COLLIMATOR CAL NEEDED MESSAGE. THERE WAS NO REPORT OF PT INJURY.
SourceopenFDA MAUDE (device adverse events)

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