Z-2439-2024 Class II Ongoing
FDA device recall Z-2439-2024 was initiated by Siemens Medical Solutions USA, Inc on Jul 3, 2024 and is designated Class II. Reason for recall: If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that… The recall status is ongoing. Affected quantity: 7 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 31, 2024
- Initiation Date
- Jul 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 systems
Product Description
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations.
Reason for Recall
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
Distribution Pattern
US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
Code Information
UDI-DI: N/A Serial Numbers: Serial 18023 18022 18020 18021 18019 18025 18017
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2439-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026