SCHICK33 S1 SENSOR/3.0 CABLE RMA KIT 9'
Received Jul 29, 2026
Report 2424472-2026-05833 · MDR key 50069968
Device
Generic name
Unit, X-ray, Intraoral
Manufacturer
Dentsply Llc York Smile WayProduct problems
- Display or Visual Feedback Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that a SCHICK33 S1 SENSOR/3.0 CABLE RMA KIT 9' did not load image from x-ray; no injury resulted.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21CFR Part 803.The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.