Acessa ProVu System 5200Recalls & reported problems

Hologic, Inc. · The Acessa ProVu Table Top Field Generator · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 15420045515284), received between Dec 12, 2024 and Dec 12, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN ACESSA PROCEDURE ON (B)(6) 2024, THE INSTRUMENTS WERE NOT COMMUNICATING ONCE IN THE PATIENT. THE PATIENT WAS CHECKED FOR NO METAL INSIDE HER BODY. THE SYSTEM WAS NOT ABLE TO FUNCTION CORRECTLY. THE CASE WAS ABORTED AND THE PATIENT RESCHEDULED. IT WAS BELIEVED THAT THE ISSUE WAS RELATED TO THE TABLETOP FIELD GENERATOR NOT FUNCTIONING CORRECTLY. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20914930 ↗

Device details

UDI-DI	`15420045515284`
Brand	Acessa ProVu System
Model	5200
Company	Hologic, Inc.
Product code	HFG · COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 16, 2024

Device type (GMDN): Electromagnetic surgical navigation device tracking system field generator

An electrically powered device intended to generate an electromagnetic (EM) field for tracking of surgical instruments with respect to real-time ultrasound images during surgery. It is designed to be connected to a control unit which is in turn connected to an endoscopic handpiece and ultrasound transducer which both feature magnetic guidance sensors. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery]. This is a reusable device.

Other COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) devices

Acessa ProVu System 7300
Hologic, Inc. · COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
1 death35 reports
CONMED 60-5163-001
Conmed Corporation · COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
4 reports
Acessa ProVu System 7100
Hologic, Inc. · COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
3 reports
Acessa ProVu System 7700
Hologic, Inc. · COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
3 reports
Acessa ProVu System 3000
Hologic, Inc. · COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
1 report

All COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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