DRX-COMPASS X-RAY SYSTEM (REF 8621617)Recalls & reported problems
Carestream Health, Inc. · X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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
- 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 ↗
Other System, x-ray, stationary devices
- FDR Visionary Suite 566-16130-23Shimadzu Corporation · System, X-Ray, Stationary4 recalls0 reports
- FDR Visionary Suite 566-16130-31Shimadzu Corporation · System, X-Ray, Stationary2 recalls0 reports
- FDR Visionary Suite 566-16130-33Shimadzu Corporation · System, X-Ray, Stationary2 recalls0 reports
- Proteus XRaGE Hualun Medical Systems Co., Ltd · System, x-ray, stationary2 recalls0 reports
- DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall8 reports
- Radiography 7300 C 712037Philips Medical Systems DMC GmbH · System, X-Ray, Stationary1 recall1 death8 reports
- DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall5 reports
- DRX-Compass X-ray SystemCarestream Health, Inc. · System, x-ray, stationary1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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