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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
InitiatedRecall #ClassStatusReasonQuantityLink basis
2023-11-23Z-3158-2024Class IIOpen, ClassifiedWhen the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.Distribution: US Nationwide and Worldwide130clearance family
2023-02-27Z-1470-2023Class IIOpen, ClassifiedArm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.Distribution: US Nationwide distribution.77 unitsclearance family
Regulatory clearances
  • 510(k)K170858Substantially equivalent (SESE) · 2017-04-24clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-03-26VAIVoluntary action indicatedFUJIFILM MEDWORK GMBH1
2023-09-22VAIVoluntary action indicatedFujifilm Corporation3
2023-09-22VAIVoluntary action indicatedFujifilm Corporation3
2023-03-10VAIVoluntary action indicatedFUJIFILM Healthcare Manufacturing Corp.0
2023-01-27VAIVoluntary action indicatedFUJIFILM Healthcare Manufacturing Corporation Sano Office2
2019-09-30OAIOfficial action indicatedFujifilm Corporation0
2019-09-30OAIOfficial action indicatedFujifilm Corporation0
2019-09-10OAIOfficial action indicatedFUJIFILM Healthcare Manufacturing Corporation Sano Office0
2019-06-21VAIVoluntary action indicatedFUJIFILM Healthcare Americas Corporation2
2018-07-13VAIVoluntary action indicatedFujifilm Corporation1
2018-07-13VAIVoluntary action indicatedFujifilm Corporation1
2018-03-29VAIVoluntary action indicatedFUJIFILM Healthcare Americas Corporation1
2018-03-09WLWarning LetterFujifilm Corporation—
2018-03-09WLWarning LetterFujifilm Corporation—
2017-12-21VAIVoluntary action indicatedFUJIFILM Corporation Medical Systems Research & Development Center Kashiwa0
2017-11-08NAINo action indicatedFUJIFILM Healthcare Americas Corporation0
2016-11-10NAINo action indicatedFUJIFILM Healthcare Americas Corporation0
2016-10-31NAINo action indicatedFUJIFILM Healthcare Americas Corporation0
2015-04-22OAIOfficial action indicatedFUJIFILM Healthcare Manufacturing Corporation Sano Office7
2015-02-19VAIVoluntary action indicatedFUJIFILM Healthcare Americas Corporation2
2014-02-19NAINo action indicatedFUJIFILM Healthcare Manufacturing Corp.0
2013-04-25NAINo action indicatedFujifilm Corporation0
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