Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 2/26/2020
Class II

PRODUCT

Luminos dRF Max, model no. 10762471 – Product Usage: Luminos dRF 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.

• Recall Number: Z-1337-2020

REASON

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

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 1/8/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

46

DISTRIBUTION

US Nationwide