Reason: In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software ve...
Z-1267-2025March 12, 2025Cleveland, OH
Philips Medical Systems Nederland B.V.
Class IIOngoing
Philips IntelliSpace Cardiovascular software, Model 830089.
Reason: Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Reason: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Z-1247-2025March 5, 2025Nussloch, N/A
INTELERAD MEDICAL SYSTEMS INCORPORATED
Class IIOngoing
IntelePACS (Image Fusion Module) - InteleViewer
Reason: A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorr...
Z-1208-2025March 5, 2025Montreal, N/A
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
Class IIOngoing
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Reason: Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded pr...
Reason: Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ acc...
Z-1206-2025March 5, 2025San Diego, CA
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Servi...
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1191-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1185-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, ...
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1195-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Serv...
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1189-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1192-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, ...
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1187-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B ...
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1190-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Servic...
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1186-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1193-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...
Z-1188-2025February 26, 2025Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3
Reason: Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment pla...