Ziehm Vision 2

• • Ongoing Z-0575-2025 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-2644-2016 FDA Class II ·initiated 15 Apr 2016 ·on shared 510(k) K073346

  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.

• 2 recalls, same reason

  • Terminated Z-0565-2014 FDA Class II ·initiated 21 Nov 2013 ·on shared 510(k) K073346
  • Terminated Z-0564-2014 FDA Class II ·initiated 21 Nov 2013 ·on shared 510(k) K073346

  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 shared 510(k) K073346

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 21 Mar 2008 Cleared FDA 510(k) K073346
2. 29 Apr 2011 Recall initiated FDA recalls Z-1430-2012
3. 21 Nov 2013 Recall initiated FDA recalls Z-0565-2014
4. 21 Nov 2013 Recall initiated FDA recalls Z-0564-2014
5. 15 Apr 2016 Recall initiated FDA recalls Z-2644-2016
6. 8 Aug 2024 Recall initiated FDA recalls Z-0575-2025

510(k) Number

K073346 ↗

FDA product code

JAK

Device class

Class II

Regulation

21 CFR Part 892.1750

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

• ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION by Philips Healthcare (Cleveland)
• CardIQ Xpress 2.0 with Snapshot Freeze Option CardIQ Xpress 2.0 Reveal by GE Medical Systems SCS
• Al-Rad Companion (Pulmonary) by SIEMENS MEDICAL SOLUTIONS USA, INC.
• MYOPERFUSION by Toshiba Medical Systems
• SOMATOM SMILE by SIEMENS MEDICAL SOLUTIONS USA, INC.
• SCAN BAND by Cook, Inc.
• HEAD-SPINE STABILIZER HSS-1 by Imaging Accessories, Inc.
• ADVANCE VESSEL ANALYSIS II by GE Healthcare
• VIATRONIC V3D CALCIUM SCORING by Viatronix, Inc.
• PRIMELUNG by Accuimage Diagnostics Corp.

• Ziehm Quantum

  Class II

  FDA 510(k) K051064 Active Cleared 26 May 2005

• Ziehm Vision Fd Digital Mobile Imaging System

  Class II

  FDA 510(k) K061534 Active Cleared 7 Jul 2006

• Ziehm Vario 3D Digital Mobile Imaging System

  Class II

  FDA 510(k) K061310 Active Cleared 7 Jul 2006

• Ziehm Vision Rfd

  Class II

  FDA 510(k) K083545 Active Cleared 15 May 2009

See all devices from Ziehm Imaging, Inc. →