inforMED
MalfunctionEAP

SCHICK33 S2 STARTER KIT/3.0 INTERFACE 9'

Received Jul 28, 2026

Report 2424472-2026-05831 · MDR key 50059743

Device

Generic name

Unit, X-ray, Intraoral

Product problems

  • Image Display Error/Artifact

Patient

Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

It was reported that, when capturing new intraoral (IO) images, a previously captured image overlaps the newly captured image.

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.