Acessa Table Top Field Generator 5200Recalls & reported problems
Acessa Health Inc. · Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. Includes TTFG Pad Set · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854763006126), received between Feb 26, 2026 and Feb 26, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE THE CUSTOMER EXPERIENCED ISSUES WITH THE 3D GUIDANCE AND THE LINES IN THE IMAGE WERE POOR AND INTERMITTENT FOR WHICH THE ULTRASOUND HANDPIECE WAS EXCHANGED (2 ULTRASOUND DEVICES USED) BUT THIS DIDN´T FIX THE ISSUE. PHYSICIAN DECIDED TO CONTINUE WITH THE PROCEDURE WITHOUT THE 3D GUIDANCE. ADDITIONAL INFORMATION WAS RECEIVED; IT WAS REPORTED THAT THE CUSTOMER HAD PREVIOUSLY DROPPED THE TABLE TOP FIELD GENERATOR (TTFG) ON A PREVIOUS PROCEDURE AND THAT THEY HAD USED IT DURING THIS PROCEDURE. THE PROCEDURE AT THE TIME HAD BEEN REPORTED TO BE COMPLETED WITHOUT PROBLEMS. THE PATIENT WAS READMITTED TO THE HOSPITAL ON A LATER DATE AND A BOWEL INJURY WAS FOUND. NO OTHER INFORMATION COULD BE OBTAINED.
Patient problems: Insufficient Information
MAUDE report 24461875 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.