Agency classClass IIOur severity:High FDA (Devices)·Z-0579-2025·Announced 2024-12-11

Ziehm Vision RFD 3D Hand Switch Defect May Cause Unintended Radiation

The Ziehm Vision RFD 3D hand switch can fail when exposed to mechanical stress like dropping, potentially initiating unintended radiation from the x-ray system.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recalls are typically scored at 4 (Severe) when injury or hospitalization is reported. However, the source text contains no report of injuries or illnesses—only the potential for unintended radiation. Per the rubric, theoretical risk-of-harm without reported injury scores at most 3 (High).

Plain-English summary

Orthoscan, Inc. has issued a Class II recall of the Ziehm Vision RFD 3D Interventional Fluoroscopic X-ray System affecting 50 devices distributed throughout the United States and Puerto Rico. The recalled units are identified by specific serial numbers ranging from 21118 to 23849.

The wired hand switch on these devices may not fully meet regulatory requirements (IEC 60601-2-54 and 21 CFR 1020.32(c)). When exposed to mechanical stress—such as drops or impacts—the switch's internal components can be irreversibly damaged, potentially causing unintended radiation emission from the x-ray unit.

Healthcare facilities and medical professionals using any of the 50 affected serial numbers should contact Orthoscan, Inc. or the distributor, Ziehm Imaging, Inc., for guidance. Do not operate affected units if the hand switch shows signs of mechanical damage or stress.

The recalled product

Product: Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
Manufacturer: Orthoscan, Inc.
Category: Medical Device — Diagnostic Imaging
Hazard: unintended-radiation
hand-switch-failure
Affected units: 50

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: EZIEZIEHMVISIONRFD3D1. Serial Numbers: 21118
21212
22040
22710
22764
23247
23248
23255
23257
23258
23259
23260
23327
23328
23329
23456
23457
23458
23459
23653

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 →

Same manufacturer · Orthoscan, Inc.

See all →

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Mobile C-arm hand switch defect may cause unintended X-ray emission
FDA (Devices) · 2024-12-11
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X-ray system hand switch may fail under mechanical stress
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Fluoroscopic X-Ray System Hand Switch May Cause Unintended Radiation
FDA (Devices) · 2024-12-11
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Fluoroscopic X-ray System Hand Switch May Fail and Cause Unintended Radiation
FDA (Devices) · 2024-12-11
High
Ziehm Vision RFD X-ray System Hand Switch May Cause Unintended Radiation
FDA (Devices) · 2024-12-11

Same hazard · unintended radiation