Device product
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Z-0577-2025
Product summary
- Firm
- Orthoscan, Inc.
- Event
- Event 95709
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0577-2025
Official wording
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.
Code information: UDI: EZIEZIEHMVISIONR1. Serial Numbers: 10295, 10490, 10656, 10716, 10997.
Distribution pattern: U.S. (including Puerto Rico).
Derived failure modes
-
Unknown
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.