Orthoscan, Ltd.
United Statesfrom the FDA registration address FDA FEI 3005254598
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 117 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Orthoscan Tau Mini C-Arm Ref K213113
Regimes: 510(k) Registry: 510(k)Orthoscan Mobile Di Mini C-Arm Ref K113708
Regimes: 510(k) Registry: 510(k)Orthoscan Fd Mini C-Arm Ref K133174
Regimes: 510(k) Registry: 510(k)OrthoScan TAU Mini C-Arm Ref K183220
Regimes: 510(k) Registry: 510(k)Orthoscan, Orthoscan Hd Ref K051754
Regimes: 510(k) Registry: 510(k)Ortelius 800 Ref K011827
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3005254598
- Address
- 14555 N. 82nd Street, SCOTTSDALE, AZ, 85260
FDA recalls
Recalls initiated per year
- 2017 4
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 7
- 2025 0
- 2026 0
2024
- 8 Aug 2024 Z-0573-2025 Class II Ongoing 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.
- 8 Aug 2024 Z-0574-2025 Class II Ongoing 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.
- 8 Aug 2024 Z-0575-2025 Class II Ongoing 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.
- 8 Aug 2024 Z-0576-2025 Class II Ongoing 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.
- 8 Aug 2024 Z-0577-2025 Class II Ongoing 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.
- 8 Aug 2024 Z-0578-2025 Class II Ongoing 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.
- 8 Aug 2024 Z-0579-2025 Class II Ongoing 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.
2017
- 31 Aug 2017 Z-0258-2018 Class II Terminated 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
Full distribution text
- 31 Aug 2017 Z-0259-2018 Class II Terminated 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
Full distribution text
- 31 Aug 2017 Z-0260-2018 Class II Terminated 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
Full distribution text
- 31 Aug 2017 Z-0258-2018 Class II Terminated 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
Show all 11 recalls
2017
- 31 Aug 2017 Z-0261-2018 Class II Terminated 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
Full distribution text
- 31 Aug 2017 Z-0261-2018 Class II Terminated 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
Frequently asked questions
How many devices does Orthoscan, Ltd. have in the registry?
The registry currently lists 6 devices for Orthoscan, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthoscan, Ltd.'s devices?
Among its 6 most recently registered devices, Orthoscan, Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Orthoscan, Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Orthoscan, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Orthoscan, Ltd.?
FDA recall records list 11 recalls initiated by Orthoscan, Ltd., the most recent initiated on 8 Aug 2024. 7 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Orthoscan, Ltd. in the registry?
The most recently registered devices listed for Orthoscan, Ltd. include Orthoscan Tau Mini C-Arm, ORTHOSCAN MOBILE DI MINI C-ARM, ORTHOSCAN FD MINI C-ARM and ORTHOSCAN, ORTHOSCAN HD.