Zenition 70

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Ongoing Z-1581-2025 FDA Class II ·initiated 25 Feb 2025

  A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

• • Ongoing Z-0353-2025 FDA Class II ·initiated 7 Oct 2024

  Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

• • Ongoing Z-0226-2024 FDA Class II ·initiated 4 Oct 2023

  Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

• • Ongoing Z-1583-2025 FDA Class II ·initiated 20 Jul 2023

  Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.

• • Ongoing Z-0648-2022 FDA Class II ·initiated 2 Dec 2021

  Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

• • Terminated Z-1933-2020 FDA Class II ·initiated 10 Apr 2020

  When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.

Trade Name

Zenition 70 EUDAMED

Zenition GUDID

Generic Name

Mobile general-purpose fluoroscopic x-ray system, digital

Model / Ref / Catalog

Zenition 70, 718133

Primary DI / UDI-DI

00884838091528

Basic UDI-DI

0884838BM350SQ, B-00884838091528

FDA Product Code

OXO, JAA, OWB

EMDN Code

Z11039017 Mobile radioscopic units

GMDN Term

Mobile general-purpose fluoroscopic x-ray system, digital

Device Class

Class IIb EUDAMED

Class II GUDID

Regulation Number

892.1650

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

EUDAMED SRN

NL-MF-000001489

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  CE/MDR

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  Class IIb

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  FDA 510(k) K254205 Active Cleared 7 Aug 2026

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  FDA 510(k) K262330 Active Cleared 30 Jul 2026

• dS FootAnkle 16Ch 1.5T

  Class II

  FDA 510(k) K262294 Active Cleared 24 Jul 2026

• Multimodality Simulation Workspace (MM Sim) Upgrade

  Class IIb

  CE/MDR GUDID on market

See all devices from Philips Medical Systems Nederland B.V. →

• What types of clinical procedures is the Zenition 70 designed to support with its imaging capabilities?

  The Zenition 70 is a mobile C-arm imaging system with a flat detector, specifically designed for radiographic procedures to provide high-resolution X-ray imaging. It is intended for intraoperative and procedural guidance across various clinical settings, such as orthopedics, trauma, or interventional radiology, where real-time imaging is critical for precision and safety.

• Is the Zenition 70 system reusable, and if not, what does this mean for its maintenance and cost?

  The Zenition 70 is explicitly designed for single-use only, meaning it is not intended to be reprocessed or reused after a single procedure. This eliminates the need for sterilization or maintenance between uses, simplifying workflows and reducing the risk of cross-contamination. However, buyers should account for the higher per-procedure cost compared to reusable systems, as each use requires a new unit.

• What flat detector options are available for the Zenition 70, and how might they affect imaging performance?

  The Zenition 70 system incorporates two flat detector models: FD12 and FD15. These detectors are likely optimized for different imaging requirements, such as field of view or resolution. While the exact specifications (e.g., size, resolution) aren’t detailed here, the choice between them would depend on clinical needs—such as the need for broader coverage (e.g., FD15) or higher detail (e.g., FD12). Consulting Philips’ technical documentation would clarify performance differences.

• How is the Zenition 70 regulated, and what does this mean for healthcare providers in terms of compliance?

  The Zenition 70 is regulated under FDA 510(k) clearance (K212813) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in Europe. This means it has undergone regulatory review for safety and performance, ensuring it meets standards for high-resolution radiographic imaging. Providers must ensure proper handling, storage, and disposal in accordance with local regulations, as it is non-sterile and single-use.

• What storage requirements should be considered for the Zenition 70 to maintain its functionality and compliance?

  Since the Zenition 70 is non-sterile and single-use, it does not require sterile storage conditions. However, it should be stored in a clean, dry environment protected from physical damage, extreme temperatures, or moisture to preserve its integrity. The system’s UDI (0884838BM350SQ) enables traceability, so storage areas should allow for easy identification and inventory management. Always follow Philips’ guidelines for unpacking and setup to ensure optimal performance.