SCHICK33 S1 STARTER KIT/3.0 INTERFACE 9'
Received Jul 27, 2026
Report 2424472-2026-05822 · MDR key 50024283
Device
Generic name
Unit, X-ray, Intraoral
Manufacturer
Dentsply Llc York Smile WayProduct problems
- Poor Quality Image
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that a SCHICK33 S1 STARTER KIT/3.0 INTERFACE 9' was having image quality issues; 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.