Recall Z-0577-2025
Orthoscan, Inc. · initiated August 8, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Codes / lots: UDI: EZIEZIEHMVISIONR1. Serial Numbers: 10295, 10490, 10656, 10716, 10997.
Reason for recall
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.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
Ziehm Imaging, Inc. intends to notify the affected customers directly in the following manner: 1) Letter with return receipt requested, envelope, return, and reply to questionnaire, or E-mail contact. 2) Direct phone calls. Once contact is made and confirmed Ziehm Imaging Inc, shall provide replacement hand switch and instructions to the end user. Wired Hand switch 88036 Vl.02 will be requested to be returned by the customer/end user to Ziehm Imaging Inc. and will be subjected to be scrapped.
Details
- Recall number
- Z-0577-2025
- Initiated
- August 8, 2024
- Posted by FDA
- December 2, 2024
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Quantity
- 5
- Distribution
- U.S. (including Puerto Rico).
- Recalling firm
- Orthoscan, Inc., Scottsdale, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0573-2025 Class II | Ziehm Solo. Digital Mobile C-armZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0574-2025 Class II | Ziehm Solo FD. Interventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0575-2025 Class II | Ziehm Vision system, x-ray, tomography, computed.Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0576-2025 Class II | Ziehm Vision FD. Interventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0578-2025 Class II | Ziehm Vision RFD. Interventional fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |
| Z-0579-2025 Class II | Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray systemZiehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed… | 08/08/2024Open, Classified |