The Recall Desk
HighFDA (Devices)·Z-0574-2025·Announced 2024-12-11

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.
Category
Medical Device — Diagnostic Imaging Equipment
Hazard
Affected units
25

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

Distributed in 1 state:

Part of a larger recall action

This product is one of 7 recalled by Orthoscan, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Orthoscan, Inc.

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Same hazard · unintended radiation

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