Recall Z-1338-2020— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1338-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-08

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-01-08, terminated 2022-06-21. It names one FDA 510(k) clearance: K173639. Product: Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.. Reason: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-01-08
Terminated: 2022-06-21
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.·cleared 2018-04-02

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

Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

Reason for recall

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

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