Orthoscan Recalls
11 recalls on record · January 17, 2018 to December 11, 2024 · Medical Devices
Recalls by year
18
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 11, 2024Medical DevicesFDA
Orthoscan, Inc. recalls Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
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.
December 11, 2024Medical DevicesFDA
Orthoscan, Inc. recalls Ziehm Vision RFD. Interventional fluoroscopic x-ray system
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.
December 11, 2024Medical DevicesFDA
Orthoscan, Inc. recalls Ziehm Vision R. Iterventional fluoroscopic x-ray system
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.
December 11, 2024Medical DevicesFDA
Orthoscan, Inc. recalls Ziehm Vision FD. Interventional fluoroscopic x-ray system
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.
December 11, 2024Medical DevicesFDA
Orthoscan, Inc. recalls Ziehm Vision system, x-ray, tomography, computed.
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.
December 11, 2024Medical DevicesFDA
Orthoscan, Inc. recalls Ziehm Solo FD. Interventional fluoroscopic x-ray system
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.
December 11, 2024Medical DevicesFDA
Orthoscan, Inc. recalls Ziehm Solo. Digital Mobile C-arm
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.
January 17, 2018Medical DevicesFDA
Orthoscan, Inc. recalls Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualizati
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
January 17, 2018Medical DevicesFDA
Orthoscan, Inc. recalls Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization
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
January 17, 2018Medical DevicesFDA
Orthoscan, Inc. recalls Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization
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
January 17, 2018Medical DevicesFDA
Orthoscan, Inc. recalls Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization
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