X-Guide P010673Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817421020995), received between Oct 29, 2021 and Oct 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 28, 2022Open, Classified

   Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.

   Z-0222-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2021Loose or Intermittent Connection

  THE DOCTOR'S PROBE TOOL TIP BECAME LOOSE DURING ORAL SURGERY WHILE HE WAS REGISTERING POINTS IN THE PATIENT'S MOUTH FOR THE X-MARK PROCESS. THE DOCTOR WAS ABLE TO RETRIEVE THE TIP BEFORE IT FELL INTO THE PATIENT'S MOUTH.

  Patient problems: Insufficient Information

  MAUDE report 12722350 ↗