Orthoscan recalls
Orthoscan appears in 11 official U.S. recall notices indexed by RecallRadar, most recently on 2024-12-11.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 11 |
|---|---|
| Published | 2018-01-17 to 2024-12-11 |
| By agency | FDA Device (11) |
| By classification | Class II (11) |
| By status | ongoing (7), terminated (4) |
| Distribution named in notices | PR, US |
Recalls
- Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan
Reason: 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 s… - Ziehm Solo
FDA Device · Class II · 2024-12-11 · Orthoscan
Reason: 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 s… - Ziehm Vision RFD. Interventional fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan
Reason: 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 s… - Ziehm Vision system, x-ray, tomography, computed
FDA Device · Class II · 2024-12-11 · Orthoscan
Reason: 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 s… - Ziehm Vision FD. Interventional fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan
Reason: 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 s… - Ziehm Solo FD. Interventional fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan
Reason: 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 s… - Ziehm Vision R. Iterventional fluoroscopic x-ray system
FDA Device · Class II · 2024-12-11 · Orthoscan
Reason: 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 s… - Mobile Mini C-arm system Part # 1000-0001
FDA Device · Class II · 2018-01-17 · Orthoscan
Reason: 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… - Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, inc…
FDA Device · Class II · 2018-01-17 · Orthoscan
Reason: 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… - Mobile Mini C-arm system Part # 1000-0005
FDA Device · Class II · 2018-01-17 · Orthoscan
Reason: 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… - Mobile Mini C-arm system Part # 1000-0004
FDA Device · Class II · 2018-01-17 · Orthoscan
Reason: 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…