Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax

• • Ongoing Z-0999-2026 FDA Class II ·initiated 5 Dec 2025

  A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

• 2 recalls, same reason

  • Ongoing Z-1982-2025 FDA Class II ·initiated 4 Jun 2025 ·on shared 510(k) K173639
  • Ongoing Z-1981-2025 FDA Class II ·initiated 4 Jun 2025 ·on shared 510(k) K173639

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

• 3 recalls, same reason

  • Ongoing Z-2527-2024 FDA Class II ·initiated 2 Jul 2024
  • Ongoing Z-2525-2024 FDA Class II ·initiated 2 Jul 2024
  • Ongoing Z-2526-2024 FDA Class II ·initiated 2 Jul 2024

  The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

• 3 recalls, same reason

  • Ongoing Z-1167-2023 FDA Class II ·initiated 21 Dec 2022
  • Ongoing Z-1168-2023 FDA Class II ·initiated 21 Dec 2022
  • Ongoing Z-1165-2023 FDA Class II ·initiated 21 Dec 2022

  Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

• • Ongoing Z-1002-2023 FDA Class II ·initiated 9 Dec 2022

  There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.

• 2 recalls, same reason

  • Ongoing Z-1480-2023 FDA Class II ·initiated 23 Nov 2022
  • Ongoing Z-1481-2023 FDA Class II ·initiated 23 Nov 2022

  Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.

• • Ongoing Z-1479-2023 FDA Class II ·initiated 23 Nov 2022

  Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.

• • Terminated Z-0806-2021 FDA Class II ·initiated 9 Sep 2020 ·on shared 510(k) K173639

  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.

• 3 recalls, same reason

  • Terminated Z-1332-2020 FDA Class II ·initiated 8 Jan 2020
  • Terminated Z-1333-2020 FDA Class II ·initiated 8 Jan 2020
  • Terminated Z-1331-2020 FDA Class II ·initiated 8 Jan 2020

  Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.

• 2 recalls, same reason

  • Terminated Z-1338-2020 FDA Class II ·initiated 8 Jan 2020
  • Terminated Z-1337-2020 FDA Class II ·initiated 8 Jan 2020

  A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

• 3 recalls, same reason

  • Terminated Z-2756-2020 FDA Class II ·initiated 8 Jan 2020 ·on shared 510(k) K173639
  • Terminated Z-2755-2020 FDA Class II ·initiated 8 Jan 2020 ·on shared 510(k) K173639
  • Terminated Z-2757-2020 FDA Class II ·initiated 8 Jan 2020 ·on shared 510(k) K173639

  Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis

• • Terminated Z-0985-2019 FDA Class II ·initiated 8 Feb 2019

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

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

510(k) Number

K173639 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Syngo.CT Vascular Analysis

  Class II

  FDA 510(k) K112020 Active Cleared 18 Aug 2011

• Acuson SC2000 Diagnostic Ultrasound System

  Class II

  FDA 510(k) K142628 Active Cleared 10 Oct 2014

• Syngo.VIA

  Class II

  FDA 510(k) K123920 Active Cleared 18 Jan 2013

• Syngo.plaza

  Class II

  FDA 510(k) K093612 Active Cleared 4 Mar 2010

• Syngo Dynamics Version 7.0

  Class II

  FDA 510(k) K081018 Active Cleared 25 Apr 2008

• MOBILETT Impact

  Class II

  FDA 510(k) K231577 Active Cleared 25 Jul 2023

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