Recall – X-ray software may incorrectly assign image

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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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