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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2019-06-20NAINo action indicatedComputerized Imaging Reference Systems, Inc0
2014-10-24NAINo action indicatedSun Nuclear Corporation0
2014-10-24NAINo action indicatedSun Nuclear Corporation0
2013-02-06WLWarning LetterSun Nuclear Corporation—
2013-02-06WLWarning LetterSun Nuclear Corporation—
2012-09-28VAIVoluntary action indicatedSun Nuclear Corporation9
2012-06-26NAINo action indicatedSun Nuclear Corporation0
2010-07-22VAIVoluntary action indicatedSun Nuclear Corporation3
2010-07-22VAIVoluntary action indicatedSun Nuclear Corporation3
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