Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

EVO Excel, Emission Computed Tomographic System, Material Number 10910501

FDA Recall Z-0372-2019 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2018-10-05
Date Terminated2021-02-11
Product Quantity264 units

Reason for Recall

The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,

Firm Action

Siemens disseminated the notices by letter on 10/05/2018. Firm will deliver a Symbia Evo Excel Addendum and DVD addendum with this updated information at a later date.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162337Symbia 6.5Siemens Medical Solutions USA, Inc. · 2016-09-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑