FDA Recall: Software error leads to incorrect collimation

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 1/8/2026
Class: II

PRODUCT:

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Recall Number:

Z-0999-2026

REASON:

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

RECALLING FIRM/MANUFACTURER:

Siemens Medical Solutions USA, Inc

VOLUME:

U.S.: 1, OUS: 95

DISTRIBUTION:

U.S. and OUS

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.