Z-0574-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- August 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 25
Product Description
Ziehm Solo FD. Interventional fluoroscopic x-ray system
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.
Distribution Pattern
U.S. (including Puerto Rico).
Code Information
UDI: EZIEZIEHMSOLOFD1 Serial Numbers: 54301, 54772, 54773, 54774, 54792, 54793, 54794, 54795, 54796, 54797, 54798, 54851, 54852, 54855, 55020, 55021, 55114, 55115, 55116, 55117, 55118, 55119, 55120, 55121, 55212.