Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 57 of 120
Ortho Clinical Diagnostics
Class II Terminated
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Reason: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Z-2480-2020 July 8, 2020 Rochester, NY
Ortho Clinical Diagnostics
Class II Terminated
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Reason: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Z-2484-2020 July 8, 2020 Rochester, NY
Fujifilm Medical Systems U.S.A., Inc.
Class II Ongoing
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
Reason: Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the...
Z-2471-2020 July 8, 2020 Lexington, MA
Preventice Services, LLC
Class II Terminated
BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the mon...
Reason: The device data being collected and transferred to the monitoring center may not be accurate due to nonvalidated association between the phone software and the heart monitors, ther...
Z-2479-2020 July 8, 2020 Houston, TX
RAYSEARCH LABORATORIES AB
Class II Ongoing
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Reason: It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found wit...
Z-2426-2020 July 1, 2020 Stockholm, N/A
Merge Healthcare, Inc.
Class II Terminated
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, pr...
Reason: An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abn...
Z-2403-2020 July 1, 2020 Hartland, WI
Abaxis Inc
Class II Terminated
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Reason: Incorrect reference ranges of analytes.
Z-2361-2020 June 24, 2020 Union City, CA
Elekta Limited
Class II Terminated
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Reason: In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitor...
Z-2297-2020 June 17, 2020 Crawley, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2346-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2352-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2351-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2344-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2350-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2353-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2339-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2349-2020 June 17, 2020 Stockholm, N/A
Becton, Dickinson and Company, BD Biosciences
Class II Terminated
BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for us...
Reason: The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline i...
Z-2356-2020 June 17, 2020 San Jose, CA
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2343-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2340-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2347-2020 June 17, 2020 Stockholm, N/A
Becton, Dickinson and Company, BD Biosciences
Class II Terminated
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intende...
Reason: The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for...
Z-2357-2020 June 17, 2020 San Jose, CA
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2341-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2342-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2348-2020 June 17, 2020 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Reason: Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Z-2345-2020 June 17, 2020 Stockholm, N/A