ZepHr Z07-2000-B-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816734022177), received between Sep 5, 2024 and Sep 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K012232); they may or may not involve this specific model.

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.

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.

• MalfunctionSep 5, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER USER FACILITY REPORT CONTAINED THE FOLLOWING INFORMATION: DESCRIBE THE EVENT OR PROBLEM: THE IMPEDANCE MACHINE WOULD NOT FUNCTION, AND REGISTERED NURSE (RN) DID NOT HAVE A REPLACEMENT MACHINE TO USE, SO THE IMPEDANCE CATHETER WAS NOT PLACED AS PLANNED. VENDOR WAS CALLED TO LET THEM KNOW THAT THE MACHINE NEEDS REPAIRED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? UPPER GASTROINTESTINAL ENDOSCOPY. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146779 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012232. One submission often covers many models, so check the product and lot details in each record.

• Z-2521-2023 · Jul 25, 2023 · Open, Classified
  ZVU Functional GI Software, REF: ZVU-3
• Z-1487-2012 · Feb 23, 2009 · Terminated
  Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary