X-ray system hand switch may fail under mechanical stress
The Ziehm Solo FD interventional fluoroscopic x-ray system's hand switch may fail when exposed to mechanical stress, potentially causing unintended radiation. Twenty-five units are affected in the U.S. and Puerto Rico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II device has a high-risk hazard (unintended radiation exposure), but no illnesses or injuries have been reported. The failure requires mechanical stress to trigger. This is a risk-of-harm product where injury has not yet been reported, meeting the criteria for Score 3.
Plain-English summary
Ziehm Imaging, Inc., the distributor, is recalling the Ziehm Solo FD Interventional fluoroscopic x-ray system due to a defect in the wired hand switch. The switch may not fully meet regulatory standards for mechanical durability.
The hand switch can fail if subjected to mechanical stress such as dropping or impacts. If the switching element becomes damaged, the x-ray unit may potentially emit unintended radiation.
Twenty-five units with specific serial numbers are affected and have been distributed throughout the United States and Puerto Rico. This is a Class II medical device recall assigned FDA recall number Z-0574-2025.
The recalled product
- Product
- Ziehm Solo FD. Interventional fluoroscopic x-ray system
- Manufacturer
- Orthoscan, Inc.
- Hazard
- unintended-radiation
- switch-failure
- mechanical-stress
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI: EZIEZIEHMSOLOFD1 Serial Numbers: 54301
- 54772
- 54773
- 54774
- 54792
- 54793
- 54794
- 54795
- 54796
- 54797
- 54798
- 54851
- 54852
- 54855
- 55020
- 55021
- 55114
- 55115
- 55116
- 55117
Distribution
Distribution scope not specified by the agency.
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