Uroskop Omnia

• 2 recalls, same reason

  • Ongoing Z-1982-2025 FDA Class II ·initiated 4 Jun 2025
  • Ongoing Z-1981-2025 FDA Class II ·initiated 4 Jun 2025

  A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

• • Terminated Z-0805-2021 FDA Class II ·initiated 9 Sep 2020

  After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.

• • Terminated Z-0984-2019 FDA Class II ·initiated 8 Feb 2019

  The swivel arm holding the monitors may become dislodged from the carrying arm.

• • Terminated Z-1670-2015 FDA Class II ·initiated 13 Apr 2015

  Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.

• • Terminated Z-0004-2015 FDA Class II ·initiated 2 Sep 2014 ·on shared 510(k) K101491

  Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images

• • Terminated Z-2292-2014 FDA Class II ·initiated 7 Jul 2014

  It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated. Thi

• • Terminated Z-0140-2014 FDA Class II ·initiated 3 Sep 2013

  When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting repetition of the examination.

• • Terminated Z-0374-2014 FDA Class II ·initiated 3 Sep 2013 ·on shared 510(k) K101491

  A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.

• • Terminated Z-1845-2014 FDA Class II ·initiated 28 Aug 2013 ·on shared 510(k) K101491

  When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination.

• • Terminated Z-0016-2014 FDA Class II ·initiated 6 May 2013 ·on shared 510(k) K101491

  Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho

• • Terminated Z-1159-2012 FDA Not yet classified ·initiated 15 Feb 2012 ·on shared 510(k) K101491

  Firm has become aware of unintended behavior when using Ysio, AXIOM dRF, AXIOM Luminos Agile/TF and Uroskop Omnia with RAD Fluoro Uro function using software version VC10A. Due to an error in the image pipeline, images may display dark and not suitable for diagnostic. Due to this software error customers have to repeat x-ray exposure to receive diagnostic images.

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

1. 28 Aug 2013 Recall initiated FDA recalls Z-1845-2014
2. 3 Sep 2013 Recall initiated FDA recalls Z-0140-2014
3. 3 Sep 2013 Recall initiated FDA recalls Z-0374-2014
4. 7 Jul 2014 Recall initiated FDA recalls Z-2292-2014
5. 2 Sep 2014 Recall initiated FDA recalls Z-0004-2015
6. 13 Apr 2015 Recall initiated FDA recalls Z-1670-2015
7. 8 Feb 2019 Recall initiated FDA recalls Z-0984-2019
8. 9 Sep 2020 Recall initiated FDA recalls Z-0805-2021
9. 4 Jun 2025 Recall initiated FDA recalls Z-1982-2025
10. 4 Jun 2025 Recall initiated FDA recalls Z-1981-2025

3 earlier events are in the sections above.

510(k) Number

K101491 ↗

FDA product code

JAA

Device class

Class II

Regulation

21 CFR Part 892.1650

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

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