Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0103-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0102-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/o...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0111-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracard...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0107-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0116-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracar...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0098-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0113-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0112-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0097-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/o...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0110-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0096-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intr...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0095-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac a...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0100-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0101-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardia...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0108-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0105-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0115-2025October 23, 2024Maple Grove, MN
Boston Scientific Corporation
Class IIOngoing
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/o...
Reason: Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c...
Z-0114-2025October 23, 2024Maple Grove, MN
Agfa Healthcare NV
Class IIOngoing
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, ...
Reason: Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect cro...
Z-0055-2025October 16, 2024Mortsel
Zyno Medical LLC
Class IOngoing
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Reason: There is a defect in the air-in-line software algorithm.
Z-0005-2025October 16, 2024Natick, MA
Philips North America
Class IIOngoing
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Reason: During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is of...
Z-0035-2025October 16, 2024Cambridge, MA
Philips North America Llc
Class IIOngoing
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062;...
Reason: Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2...
Z-0020-2025October 16, 2024Cambridge, MA
Becton Dickinson & Co.
Class IIOngoing
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality a...
Reason: Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoint...
Z-0026-2025October 16, 2024Sparks, MD
Beckman Coulter, Inc.
Class IIOngoing
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentra...
Reason: When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process t...
Z-0025-2025October 16, 2024Chaska, MN
Medtronic Navigation, Inc.
Class IIOngoing
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures i...
Reason: Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, informa...