Siemens Medical Solutions USA, Inc: Device Recall

Recall #Z-2441-2024 · 07/03/2024

Class II: Risk

Recall Details

Recall Number: Z-2441-2024
Classification: Class II
Product Type: Device
Recalling Firm: Siemens Medical Solutions USA, Inc
Status: Ongoing
Date Initiated: 07/03/2024
Location: Malvern, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12 units

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.

Product Description

Sensis Vibe systems with software version VD15B-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: 11007641

Distribution Pattern

US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.

Other Recalls by Siemens Medical Solutions USA, Inc

Class II: Risk 12/29/2025

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk 12/29/2025

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

View all recalls by Siemens Medical Solutions USA, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.