iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data
Reason: The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the prog...
Z-1697-2017April 5, 2017Hartland, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a...
Reason: Software changes now available to address several issues
Z-1689-2017April 5, 2017Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a s...
Reason: Software changes now available to address several issues
Z-1688-2017April 5, 2017Malvern, PA
Baxter Healthcare Corporation
Class IITerminated
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Reason: SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software a...
Z-1693-2017April 5, 2017Medina, NY
Respironics California Inc
Class IITerminated
Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,Engl...
Reason: The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to s...
Z-1687-2017April 5, 2017Carlsbad, CA
Merge Healthcare, Inc.
Class IITerminated
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Reason: The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
Z-1681-2017April 5, 2017Hartland, WI
Hospira Inc., A Pfizer Company
Class IITerminated
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Reason: Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reb...
Z-1682-2017April 5, 2017Lake Forest, IL
Merge Healthcare, Inc.
Class IITerminated
iConnect Enterprise Archive software.
Reason: The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determ...
Z-1700-2017April 5, 2017Hartland, WI
Data Innovations, LLC
Class IITerminated
JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments an...
Reason: Software issue resulting in the results of one patient potentially being associated with another.
Z-1680-2017April 5, 2017South Burlington, VT
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and ...
Reason: Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpr...
Z-1517-2017March 29, 2017Hartland, WI
Nidek Inc
Class IITerminated
Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation o...
Reason: During treatment planning, the procedure was programmed with an unintended (wrong) correction.
Z-1494-2017March 29, 2017Fremont, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
Reason: Software update
Z-1491-2017March 29, 2017Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification promp...
Z-1415-2017March 29, 2017Hartland, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute,...
Reason: Software updates
Z-1533-2017March 29, 2017Malvern, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at differ...
Reason: Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retro...
Z-1493-2017March 29, 2017Cleveland, OH
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same pati...
Z-1496-2017March 29, 2017Hartland, WI
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the follow...
Reason: Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecti...
Z-1537-2017March 29, 2017Tarrytown, NY
Siemens Medical Solutions USA, Inc
Class IITerminated
ONCOR" Avant-garde
Reason: Software update
Z-1490-2017March 29, 2017Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
ARTISTE" MV System
Reason: Software update
Z-1488-2017March 29, 2017Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
Merge Cardio software.
Reason: Cardio study list does not show STAT studies without refreshing.
Z-1486-2017March 29, 2017Hartland, WI
Haag-Streit USA Inc
Class IITerminated
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Reason: There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Z-1500-2017March 29, 2017Mason, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
Mevatron M2/Primus Mid-Energy PRIMUS HI
Reason: Software update
Z-1489-2017March 29, 2017Malvern, PA
Merge Healthcare, Inc.
Class IITerminated
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
Reason: The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.
Z-1470-2017March 22, 2017Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
Reason: In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.
Z-1457-2017March 22, 2017Hartland, WI
Merge Healthcare, Inc.
Class IITerminated
Merge PACS software. The firm name on the label is Merge Healthcare.
Reason: Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.