FDA Enforcement
Class II
Ongoing
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
Recall: Z-2438-2024
·
Reported July 31, 2024
Enforcement
- Recall Number
- Z-2438-2024
- Event ID
- 94956
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 31, 2024
- Initiation Date
- July 3, 2024
- Classification Date
- July 25, 2024
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418, United States
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
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.
Code Info
UDI-DI: N/A Serial Numbers: 15000 15001 15003
Distribution
US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
Quantity
3 systems