InSight 2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045505896), received between May 7, 2019 and May 7, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K051025); 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.

• MalfunctionMay 7, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY A DISTRIBUTOR, WHO RECEIVED A PHONE CALL DIRECTLY FROM THE CUSTOMER, THAT DUE TO AN "UNRULY FLEX ARM" A MEMBER OF THE STAFF WAS INJURED. THE SEVERITY OF THE INJURY OR MEDICAL INTERVENTION WAS NOT REPORTED. A FIELD ENGINEER HAD PREVIOUSLY BEEN DISPATCHED TO THE SITE AND DETERMINED THAT THE FLEX ARM NEEDED TO BE REPLACED. THE INSIGHT SYSTEM HAS BEEN REPLACED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED INJURY ON (B)(6) 2019 HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Information

  MAUDE report 8587901 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051025. One submission often covers many models, so check the product and lot details in each record.

• Z-1326-2013 · Apr 25, 2013 · Terminated
  Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visua
• Z-1327-2013 · Apr 25, 2013 · Terminated
  Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluorosc
• Z-2453-2012 · Sep 14, 2012 · Terminated
  Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with ge
• Z-2452-2012 · Sep 14, 2012 · Terminated
  Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with gene