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