Home / Recalls / Siemens Medical Solutions USA, Inc / Z-2478-2018

Z-2478-2018 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-2478-2018 was initiated by Siemens Medical Solutions USA, Inc on Feb 1, 2018 and is designated Class II. Reason for recall: A potential risk of unnecessary radiation exposure due to a software issue The recall status is terminated (terminated May 1, 2020).

Recall Details

Product Type: Devices
Report Date: Aug 8, 2018
Initiation Date: Feb 1, 2018
Termination Date: May 1, 2020
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

SOMATOM Spirit(Model 10045692 )

Reason for Recall

A potential risk of unnecessary radiation exposure due to a software issue

Distribution Pattern

Nationwide

Code Information

Serial No. 31621 31245 79670 31092 31313 31611

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2478-2018
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.