FDAAugust 31, 2017device
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
What to do
FDA enforcement status: Terminated
Brands named
orthoscan
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAZiehm Vision R. Iterventional fluoroscopic x-ray system2024-08-08
- FDAZiehm Vision RFD. Interventional fluoroscopic x-ray system2024-08-08
- FDAZiehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system2024-08-08
- FDAZiehm Vision system, x-ray, tomography, computed.2024-08-08
- FDAZiehm Solo. Digital Mobile C-arm2024-08-08
- FDAZiehm Solo FD. Interventional fluoroscopic x-ray system2024-08-08
- FDAZiehm Vision FD. Interventional fluoroscopic x-ray system2024-08-08
- FDAMobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.2017-08-31
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