Siemens Medical Solutions USA, Inc: Device Recall

Recall Details

Recall Number

Z-1240-2026

Classification

Class II

Product Type

Device

Recalling Firm

Siemens Medical Solutions USA, Inc

Status

Ongoing

Date Initiated

12/19/2025

Location

Malvern, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

88 units

Reason for Recall

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

Product Description

NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Costa Rica, India, Israel.

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 →