inSIGHT Ultima H12R-2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816734021941), received between Oct 24, 2019 and Oct 24, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionOct 24, 2019No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER CUSTOMER REPORT MW5087436 "UNABLE TO INITIATE THE USE OF THE SANDHILL SCIENTIFIC INSIGHT ULTIMA, MANOMETRY SYSTEM AFTER NUMEROUS ATTEMPTS."

  Patient problems: No Patient Involvement

  MAUDE report 9234865 ↗

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