DRX-COMPASS X-RAY SYSTEMRecalls & reported problems across all models
Carestream Health, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one DRX-COMPASS X-RAY SYSTEM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of DRX-COMPASS X-RAY SYSTEM by Carestream Health, Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
DRX-COMPASS X-RAY SYSTEM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 30, 2023Class IIOpen, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported DRX-COMPASS X-RAY SYSTEM problems
Device problems
- Loss of Data1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
DRX-COMPASS X-RAY SYSTEM models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DRX-Compass X-ray SystemSystem, x-ray, stationary1 recall2 reports
- DRX-COMPASS X-RAY SYSTEMSystem, x-ray, stationary1 recall0 reports
Recent DRX-COMPASS X-RAY SYSTEM adverse event reports
The 2 most recent reports across all models, 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 ↗
Other Carestream Health, Inc. products
All Carestream Health, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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