Z-2438-2024 Class II Ongoing
FDA device recall Z-2438-2024 was initiated by Siemens Medical Solutions USA, Inc on July 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 th… The recall status is ongoing. Affected quantity: 3 systems.
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2024
- Initiation Date
- July 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 systems
Product Description
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -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. Model: 10910620
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: 15000 15001 15003