Recall Z-0372-2019— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0372-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-05

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2018-10-05, terminated 2021-02-11. It names one FDA 510(k) clearance: K162337. Product: EVO Excel, Emission Computed Tomographic System, Material Number 10910501. Reason: The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,.

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-05
Terminated: 2021-02-11
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K162337 — Symbia 6.5Siemens Medical Solutions USA, Inc.·cleared 2016-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EVO Excel, Emission Computed Tomographic System, Material Number 10910501

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.