inforMED
MalfunctionLLZ

SECURVIEW DX

Received Jun 12, 2026 · Event occurred May 15, 2026

Report 3005496266-2026-00153 · MDR key 25494524

Device

Generic name

System, Image Processing, Radiological

Manufacturer

Hologic, Inc

Model number

SVDX-01200

Catalog number

SVDX-01200

Product problems

  • Battery Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2026, DURING USE OF A SECURVIEW-DX 1200 SYSTEM, THE UNINTERRUPTIBLE POWER SUPPLY (UPS) BATTERY PERCENTAGE WAS LOW. THE USER SITE REPORTED THAT THE EVENT OCCURRED PRIOR TO A PATIENT EXAM/PROCEDURE. NO PATIENT OR USER INJURIES WERE REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE DEVICE AND CONFIRMED THAT THE WORKSTATION COMPUTER WAS NOT POWERING ON, WHILE THE MONITORS REMAINED OPERATIONAL. THE FSE REPORTED THAT SPARKS WERE SEEN COMING FROM THE UNINTERRUPTIBLE POWER SUPPLY (UPS) AND THAT THE WORKSTATION COMPUTER WOULD NOT POWER ON. THE FSE REPORTED THAT THE REPLACEMENT OF THE UPS WAS DELIVERED TO THE SITE AND A REPLACEMENT WORKSTATION COMPUTER WAS ORDERED. THE FSE REPORTED THAT THEY INSTALLED A CLIENT TOWER THAT WAS NOT IN USE TO RESTORE SYSTEM FUNCTIONALITY. THE FSE REPORTED THAT THE SYSTEM WAS VERIFIED TO BE OPERATING ACCORDING TO MANUFACTURER SPECIFICATIONS PENDING INSTALLATION OF THE REPLACEMENT COMPUTER. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.