Z-2472-2018 Class II Terminated

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

FDA device recall Z-2472-2018 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 Emotion 6 (Model 10165888)

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Serial No. 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2472-2018
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.