fda
8 records
FDA Device Recall: Ziehm Solo. Digital Mobile C-arm
2024-12-11
Class II — 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...
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FDA Device Recall: Ziehm Solo FD. Interventional fluoroscopic x-ray system
2024-12-11
Class II — 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...
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FDA Device Recall: Ziehm Vision RFD. Interventional fluoroscopic x-ray system
2024-12-11
Class II — 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...
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FDA Device Recall: Ziehm Vision system, x-ray, tomography, computed.
2024-12-11
Class II — 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...
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FDA Device Recall: Ziehm Vision R. Iterventional fluoroscopic x-ray system
2024-12-11
Class II — 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...
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FDA Device Recall: Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician
2018-01-17
Class II — 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 feat...
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FDA Device Recall: Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physici
2018-01-17
Class II — 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 feat...
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FDA Device Recall: Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician
2018-01-17
Class II — 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 feat...
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ny_corps
1 records
NY Corp: ORTHOSCAN, INC.
2009-12-02
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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