CombiDiagnost R90 709030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838076747), received between Aug 12, 2019 and Aug 26, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Fell” (5 reports).

3 FDA recall records name this device's identifier, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 21, 2023Class IIOpen, Classified

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

   Z-0271-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 11, 2022Class IIOpen, Classified

   While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

   Z-1087-2024 · Root cause: Software design · Recall details · FDA record ↗

3. Oct 21, 2021Class IIOpen, Classified

   If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.

   Z-1355-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

  IT WAS REPORTED THAT THE REMOTE ALERT OF A MECHANICAL HEAVY SHOCK TO THE DETECTOR. THE DEVICE WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892437 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BASE WHERE THE PATIENT WAS PLACED HAD BROKEN. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. ADDITIONAL INFORMATION RECEIVED THAT THE WHEEL INSIDE THE FOOTREST WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22069033 ↗
• MalfunctionOct 12, 2024Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT DURING CLINICAL USE, WHEN SETTING UP THE ROOM FOR EXAMINATION FOR A THORAX EXAMINATION WHERE THE TABLE WAS VERTICAL WITH SOURCE IMAGE DISTANCE OF 150 CM, THE STAND GEOMETRY OF THE SYSTEM FELL DOWN ON THE FLOOR. THE CHAIN IN THE STAND GEOMETRY SNAPPED WHEN THE USER WAS ATTEMPTING TO TILT UPWARDS AT 5 DEGREE ANGLE RESULTING IN FALLING DOWN OF THE COLLIMATOR AND THE TUBE. IT WAS CONFIRMED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20435005 ↗
• MalfunctionApr 26, 2024Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

  THE CUSTOMER REPORTED THAT THE PORTABLE DETECTOR FAILED THE GAIN CALIBRATION DURING THE QUARTERLY CHECK. 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 19191028 ↗
• MalfunctionAug 23, 2023Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

  THE CUSTOMER REPORTED THAT THE PORTABLE DETECTOR HAS FALLEN DOWN. 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 17603346 ↗
• MalfunctionAug 8, 2023Poor Quality Image; Device Handling Problem; Device Fell; Poor Quality Image; Device Handling Problem; Device Fell

  THE CUSTOMER REPORTED THAT THE PORTABLE DETECTOR FELL AND HAS NOW ARTEFACTS IN THE IMAGE. 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 17480266 ↗
• MalfunctionMar 15, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS IDENTIFIED THAT AN OBSOLETE SPDU (SYSTEM POWER DISTRIBUTION UNIT) SPARE PART IS INSTALLED IN A COMBIDIAGNOST SYSTEM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544522 ↗
• MalfunctionOct 8, 2019Device Emits Odor

  THE CUSTOMER COMPLAINED ABOUT A BURNING SMELL FROM THE SYSTEM. NO INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9166537 ↗
• MalfunctionAug 12, 2019Smoking

  THE CUSTOMER COMPLAINED ABOUT THE SYSTEM POWER DISTRIBUTION UNIT (IN SHORT NAMED SPDU) PRODUCED A SIGNIFICANT AMOUNT OF SMOKE. HOSPITALS SMOKE SENSOR WAS ACTIVATED AND THE FIRE DEPARTMENT WAS INVOLVED.. NO PATIENT INVOLVEMENT

  Patient problems: No Patient Involvement

  MAUDE report 8883839 ↗