DeviceSignal · Recall classified
Canon Medical System, USA, INC.
FDA classified a device recall on 2026-08-25 · Class II · Z-3014-2026
EventRecall classified
Effective2026-08-25
ClassificationClass II
On 2026-08-25 the FDA classified a device recall from Canon Medical System, USA, INC. as Class II. Product: Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital…. Recall Z-3014-2026. The firm initiated it on 2026-08-04. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3014-2026
- Classification
- Class II
- Classified on
- 2026-08-25
- Initiated on
- 2026-08-04
- Firm
- Canon Medical System, USA, INC.
- Reason
- Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
- Product
- Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3014-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
a46e656534ec7a09b6bb559d051a2ac078be4c77b846e28a0a15ed00139ca6b9- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)