FDA Enforcement
Class II
Ongoing
Ziehm Vision R. Iterventional fluoroscopic x-ray system
Recall: Z-0577-2025
·
Reported December 11, 2024
Enforcement
- Recall Number
- Z-0577-2025
- Event ID
- 95709
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Orthoscan, Inc.
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- December 11, 2024
- Initiation Date
- August 8, 2024
- Classification Date
- December 2, 2024
- Address
- 14555 N 82nd St, Scottsdale, AZ, 85260-2525, United States
Description
Ziehm Vision R. Iterventional fluoroscopic x-ray system
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 Info
UDI: EZIEZIEHMVISIONR1. Serial Numbers: 10295, 10490, 10656, 10716, 10997.
Distribution
U.S. (including Puerto Rico).
Quantity
5