DigitalDiagnost 712033Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838074521), received between Aug 16, 2023 and Apr 1, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Fell” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 21, 2023Open, Classified

   Potential for units suspended on the ceiling to fail and fall.

   Z-0272-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STITCHING STAND HYDRAULIC RAM HAS COME LOOSE. THE DEVICE WAS NOT IN CLINICAL USE, AND THERE WAS NO HARM TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24751380 ↗
• MalfunctionDec 16, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

  IT WAS REPORTED THAT THE SKYPLATE DETECTOR DROPPED AND HEAVY SHOCK REGISTERED TO THE DETECTOR. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818699 ↗
• MalfunctionSep 9, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

  IT WAS REPORTED THAT THE DROPPED CASSETTE, IMAGE QUALITY PROBLEM. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23002642 ↗
• MalfunctionMar 6, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

  IT WAS REPORTED THAT THE DETECTOR HAS A DENT IN THE SURFACE. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER. ADDITIONAL INFORMATION RECEIVED FROM REMOTE SERVICE ENGINEER AS DETECTOR DROPPED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534465 ↗
• MalfunctionApr 30, 2024Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

  THE CUSTOMER REPORTED THAT THE PORTABLE DETECTOR FELL. A DROPPED DETECTOR CAN LEAD IN WORST CASE TO A FRACTURE IN THE FOOT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213370 ↗
• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE TUBE IS NEARLY COMING OFF THE CEILING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555052 ↗