Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 8/12/2020
Class II
PRODUCT
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Recall Number: Z-2755-2020
REASON
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc. on 1/8/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
U.S. Nationwide