UNK PREV
Received Apr 13, 2026
Report 2424472-2026-00641 · MDR key 24856636
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. USB 3 FIRMWARE V1.4 CONTAINS AN ISSUE IN THE PORTION OF CODE USED TO OPTIMIZE SENSOR PERFORMANCE. IF THE OPTIMIZATION OCCURS DURING AN EXPOSURE OR SENSOR READOUT, THERE IS A CHANCE THAT THE RESULTING IMAGE WILL BE CORRUPTED. IMAGE DATA FOLLOWING THE POINT OF CORRUPTION WILL CONSIST OF DATA THAT WAS PREVIOUSLY HELD IN THE MEMORY OF THE USB DEVICE. AS A RESULT, THE PRESENTED IMAGE MAY CONTAIN A PORTION OF DATA FROM A PREVIOUS EXPOSURE. IN GENERAL, THIS WOULD BE OBVIOUS TO THE USER SINCE THE PRESENTED IMAGE WOULD EITHER CONTAIN OBVIOUS ARTIFACTS OR DIFFERENT ANATOMY THAN EXPECTED.
Description of Event or Problem
WHILE THE CUSTOMER WAS USING A PART OF AN INTRAORAL SENSOR SYSTEM, THEY ALLEGE THERE WAS A DEVICE RESPONSE ISSUE WHERE THE X-RAY IMAGE WAS NOT CAPTURED AFTER RADIATION HAS OCCURRED (NO DEVICE OUTPUT). NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.