Siemens Medical Solutions USA, Inc: Device Recall

Recall Details

Recall Number

Z-2438-2024

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

3 systems

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 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

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 →