Skip to content

Ziehm Solo

by Ziehm Imaging GmbH

Ziehm Solo is a Class II device made by Ziehm Imaging GmbH, cleared under FDA 510(k) K092438 on 23 Dec 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI EZIEZIEHMSOLO1), active (FDA 510(k)), not in commercial distribution (GUDID) as of 12 Nov 2026. 4 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K092438

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEZIEZIEHMSOLO1 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK092438 Date23 Dec 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092438 decided 23 Dec 2009 Active
  • FDA GUDID UDI-DI EZIEZIEHMSOLO1 listed 23 Sep 2016 Listed

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-0573-2025 FDA Class II initiated 8 Aug 2024

    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.

    • Terminated Z-2643-2016 FDA Class II initiated 15 Apr 2016

    Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

    • Terminated Z-0563-2014 FDA Class II initiated 21 Nov 2013

    Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.

    • Terminated Z-1430-2012 FDA Unclassified (pre-2012) initiated 29 Apr 2011

    On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional continued activation of fluoroscopic X-ray as the foot switch may not become inactive when the pedal is released.

Timeline

6 dated events

  1. Cleared FDA 510(k) K092438
  2. Recall initiated FDA recalls Z-1430-2012
  3. Recall initiated FDA recalls Z-0563-2014
  4. Recall initiated FDA recalls Z-2643-2016
  5. Listed FDA GUDID EZIEZIEHMSOLO1
  6. Recall initiated FDA recalls Z-0573-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Mobile general-purpose fluoroscopic x-ray system, digital
Model / reference
Solo
Primary DI / UDI-DI
EZIEZIEHMSOLO1
510(k) Number
FDA product code
OXO, JAA, OWB
GMDN term
Mobile general-purpose fluoroscopic x-ray system, digital
Device class
Class II
Regulation number
892.1650
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile).

Other devices from Ziehm Imaging GmbH

See all devices from Ziehm Imaging GmbH →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)