Ziehm Vision FD. Interventional fluoroscopic x-ray system
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.
What to do
FDA enforcement status: Ongoing
Brands named
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 system, x-ray, tomography, computed.2024-08-08
- FDAZiehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system2024-08-08
- FDAZiehm Solo. Digital Mobile C-arm2024-08-08
- FDAZiehm Solo 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
- FDAMobile Mini C-arm system Part # 1000-0001. 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
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →