OBView 4.8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857050006014), received between Jun 26, 2023 and Jun 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. Jun 26, 2023Open, Classified

   Software issue

   Z-2214-2023 · Root cause: Labeling design · 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.

• MalfunctionJun 26, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  WHEN THE GA (GESTATIONAL AGE) BY LMP (LAST MENSTRUAL CYCLE) IS SELECTED BUT THE GA BY SONOGRAPHIC IS SIGNIFICANTLY DISCORDANT TO THAT, IT CAUSES A DISCORDANCE IN THE FW% (FETAL WEIGHT PERCENTILE) BECAUSE THE FW ITSELF IS ALWAYS BASED ON SONOGRAPHIC MEASUREMENTS, BUT THE FW% COMPARES THE FW TO THE NORMAL RANGE FOR THE SELECTED GA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17201748 ↗