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Multitom Rax 10860700

by Siemens Healthcare GmbH

Ref 10860700Model MDR_16_II b_ERLN H 127_RF_combi

Multitom Rax 10860700 is a medical device (EU MDR Class IIb; FDA Class II; EMDN category fluoroscopy devices) made by Siemens Healthcare GmbH, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0405686901995WU), cleared under FDA 510(k) K221281 on 17 Nov 2022 (3 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04056869009179), active as of 12 Nov 2026. 25 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

14 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221281

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686901995WU Basic UDI-DI 04056869009179UDI-DIDate28 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK221281 Date17 Nov 2022DecidedStatusActive
United StatesGUDID listing GUDID Number04056869009179 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686901995WU registered 28 May 2026 Active
  • FDA 510(k) K221281 decided 17 Nov 2022 Active· +3 more in the status table
  • FDA GUDID UDI-DI 04056869009179 listed 24 Sep 2016 Listed

Recalls

25 recalls · 14 ongoing · FDA

    • 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
    • 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.

  • 4 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
    • Ongoing Z-2528-2024 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.

    • 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.

  • 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.

    • Terminated Z-1685-2021 FDA Class II initiated 20 Apr 2021

    Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube being misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range. AND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.

    • Terminated Z-0806-2021 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.

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

  • 3 recalls, same reason

    • Terminated Z-2756-2020 FDA Class II initiated 8 Jan 2020
    • Terminated Z-2755-2020 FDA Class II initiated 8 Jan 2020
    • Terminated Z-2757-2020 FDA Class II initiated 8 Jan 2020

    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.

Timeline

31 dated events

  1. Recall initiated FDA recalls Z-1168-2023
  2. Recall initiated FDA recalls Z-1165-2023
  3. Recall initiated FDA recalls Z-2527-2024
  4. Recall initiated FDA recalls Z-2525-2024
  5. Recall initiated FDA recalls Z-2526-2024
  6. Recall initiated FDA recalls Z-2528-2024
  7. Recall initiated FDA recalls Z-1982-2025
  8. Recall initiated FDA recalls Z-1981-2025
  9. Recall initiated FDA recalls Z-0999-2026
  10. Registered EUDAMED 0405686901995WU

21 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Multitom Rax
Generic name
Stationary general-purpose fluoroscopic x-ray system, digital
Device name
MDR_16_II b_ERLN H 127_RF_combi
Model / Ref / Catalog
10860700, MDR_16_II b_ERLN H 127_RF_combi
Primary DI / UDI-DI
04056869009179
Basic UDI-DI
0405686901995WU
510(k) Number
FDA product code
OWB, JAK, JAA
EMDN code
Z11039009 Fluoroscopy devices
GMDN term
Stationary general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650, 892.1750
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Stationary general-purpose fluoroscopic x-ray system, digital

Cleared under the same submission (K173639)

Similar devices in this category

Other devices filed under FLUOROSCOPY DEVICES.

Other devices from Siemens Healthcare GmbH

See all devices from Siemens Healthcare GmbH →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)