Agency classClass IIOur severity:High FDA (Devices)·Z-0573-2025·Announced 2024-12-11

Mobile C-arm hand switch defect may cause unintended X-ray emission

Ziehm Solo Digital Mobile C-arm devices may have hand switch defects that can cause unintended radiation emission when exposed to impacts or drops. The recalled units have been distributed in the U.S. and Puerto Rico.

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: This is a Class II medical device recall involving potential unintended radiation exposure from an X-ray imaging device. Although no injuries or deaths have been reported, the hazard of unintended radiation constitutes a significant risk to patients and operators, meeting the criterion for High severity.

Plain-English summary

Ziehm Imaging and manufacturer Orthoscan, Inc. are recalling 28 Ziehm Solo Digital Mobile C-arm devices distributed in the U.S. and Puerto Rico. The wired hand switch on these devices may fail when exposed to mechanical stress, such as impacts or drops.

Failure of the hand switch can irreversibly damage the switching element, which may then potentially cause the X-ray unit to emit unintended radiation, creating a risk of unexpected X-ray exposure.

The devices do not fully meet the requirements of IEC 60601-2-54 and 21 CFR 1020.32(c) regarding the performance and safety of wired hand switches. Users should verify their device's serial number against the recall notice to determine if their unit is affected.

The recalled product

Product: Ziehm Solo. Digital Mobile C-arm
Manufacturer: Orthoscan, Inc.
Category: Medical Device — X-ray imaging
Hazard: unintended-radiation
mechanical-failure
hand-switch-malfunction
Affected units: 28

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: EZIEZIEHSOLO1. Serial Numbers: 50652
51087
51265
52387
52889
53255
54259
54820
54821
54823
54824
54825
54826
55053
55066
55073
55074
55075
55076
55145

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 →

High
X-ray system hand switch may fail under mechanical stress
FDA (Devices) · 2024-12-11
High
Fluoroscopic X-Ray System Hand Switch May Cause Unintended Radiation
FDA (Devices) · 2024-12-11
High
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
High
X-ray system hand switch may fail, risking unintended radiation exposure
FDA (Devices) · 2024-12-11

Same hazard · unintended radiation