MalfunctionEAP
SCHICK33 S2 SENSOR SHIP KIT, 6FT
Received Jul 27, 2026
Report 2424472-2026-05817 · MDR key 50009283
Device
Generic name
Unit, X-ray, Intraoral
Manufacturer
Dentsply Llc York Smile WayCatalog number
B1209000
Lot number
NA
Product problems
- Poor Quality Image
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported there was a malfunction where image quality issues were experienced, resulting in at least 6 images to be taken.
Additional Manufacturer Narrative
Dentsply Sirona became aware of a malfunction for same/similar devices that could have possibly caused or contributed to a serious injury. Product return has been requested and will be evaluated after receipt. In case any new or additional information will be gained from this investigation a follow-up report will be sent. We will continue to track and monitor the trend.