Scottsdale, AZ, United States
Orthoscan, Inc. recalls
2 recalls recorded since 2018, most recently on 8 August 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 August 2024
- 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 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.
- Distribution
- U.S. (including Puerto Rico).
- Initiated
- FDA Mandated
- Recall numbers
- Z-0573-2025, Z-0574-2025, Z-0578-2025, Z-0575-2025, Z-0577-2025, Z-0579-2025, Z-0576-2025
- Ziehm Solo. Digital Mobile C-arm
- Ziehm Solo FD. Interventional fluoroscopic x-ray system
- Ziehm Vision RFD. Interventional fluoroscopic x-ray system
- Ziehm Vision system, x-ray, tomography, computed.
- Ziehm Vision R. Iterventional fluoroscopic x-ray system
- Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
- Ziehm Vision FD. Interventional fluoroscopic x-ray system
Terminated Class II Medical devices
- Recall started
- 31 August 2017
- Terminated
- 21 April 2021
- 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 live image exposing a larger x-ray field than can be viewed by the user
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Pol
- Initiated
- FDA Mandated
- Recall numbers
- Z-0259-2018, Z-0261-2018, Z-0258-2018, Z-0260-2018
- 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 emer
- Mobile 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 em
- Mobile 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 emer
- Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emer
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.