Siemens Medical Solutions USA, Inc: Device Recall

Recall Details

Recall Number

Z-2439-2024

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

7 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 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.

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 →