DRX-Compass X-ray System (REF 8624181)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 60889978624188), received between Jan 31, 2023 and Dec 22, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loss of Data” (1 report).

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. Jan 30, 2023Open, Classified

   After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury

   Z-1206-2023 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Loss of Data; Loss of Data

  ON 15-DEC-2025, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-COMPASS SYSTEM THAT OCCURRED ON 28-NOV-2025. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866154 ↗
• MalfunctionJan 31, 2023Unintended Movement; Unintended Movement

  ON 06-JAN-2023, CARESTREAM HEALTH WAS INFORMED BY A DEALER OF A CUSTOMER ISSUE "WHEN TRYING TO PUSH OTC Z AXIS MOTOR DOWN BUTTON, AFTER RELEASING THE BUTTON, OTC CONTINUED TO MOVE DOWN ON ITS OWN. TECH PRESSED THE "ALL BRAKE RELEASE" BUTTON TO STOP THE MOVEMENT. THE ISSUE WAS INTERMITTENT." THERE WAS NO INJURY TO THE PATIENT OR THE TECH/OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271767 ↗