Company:Medtronic Inc., Cardiac Rhythm and Heart FailureDate of Enforcement Report 1/31/2018 Class lI: PRODUCT MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device Recall Number Z-0400-2018 REASON Patients monitored on two (2) or...Read More

Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 1/31/2018 Class lI: PRODUCT Brilliance iCT SP – Model 728311 Brilliance iCT – Model 728306 Computed Tomography X-ray systems Recall Number Z-0402-2018 REASON Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 1/31/2018 Class lI: PRODUCT Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning. Recall...Read More

Company:Phadia US Inc.Date of Enforcement Report 1/24/2018 Class lI: PRODUCT Phadia 1000 Instrument, Article Number 12-3800-01.. Recall Number Z-0387-2018 REASON The “Retry” command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results RECALLING FIRM/MANUFACTURER Phadia US Inc, Portage, MI. on 7/5/2017. Voluntary firm...Read More

Company:RAYSEARCH LABORATORIES AB. Date of Enforcement Report 1/24/2018 Class lI: PRODUCT RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and...Read More

Company:OrthoScan IncDate of Enforcement Report 1/17/2018 Class lI: PRODUCT Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.. Recall Number Z-0258-2018 to Z-0261-2018 REASON OrthoScan Inc. discovered during investigation of a...Read More

Company:Invivo CorporationDate of Enforcement Report 12/27/2017 Class lI: PRODUCT Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.. Recall Number Z-0263-2018 REASON Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results....Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report 12/20/2017 Class lI: PRODUCT enGen Track System with TCAutomation Software Version 4.2 Recall Number Z-0254-2018 REASON A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN...Read More

Company:Normand InformatiqueDate of Enforcement Report 12/20/2017 Class lI: PRODUCT Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta...Read More

Company:Radiometer America Date of Enforcement Report 12/20/2017 Class lI: PRODUCT ABL800 analyzer with FLEXQ module.Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) – in...Read More

Company:ICU Medical IncDate of Enforcement Report 12/13/2017 Class lI: PRODUCT ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers:(a) 16037-64-01; MedNet 6.1b) 16037-64-02; MedNet 6.1c) 16037-64-03; MedNet 6.1d) 16037-64-04; MedNet 6.21The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion...Read More

Company:Roche Diabetes Care, Inc.Date of Enforcement Report 12/13/2017 Class lI: PRODUCT Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood...Read More

Company:GE Medical Systems Information Technologies, Inc.Date of Enforcement Report 12/13/2017 Class lI: PRODUCT CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier softwareThe PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 12/6/2017 Class lI: PRODUCT Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Recall Number Z-0177-2018 REASON A design change was...Read More

Company:Volcano Corp.Date of Enforcement Report 12/6/2017 Class lI: PRODUCT Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished...Read More

Company:BRAINLAB AGDate of Enforcement Report 12/6/2017 Class lI: PRODUCT BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 12/6/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional...Read More

Company:Spacelabs Healthcare, Ltd.Date of Enforcement Report 11/29/2017 Class l: PRODUCT Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 11/29/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8. Recall Number Z-0115-2018 REASON Potential for software to change the final tool orientation for the command position without command. RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc.Warsaw, IN on 4/8/2016. Voluntary firm initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 64 units DISTRIBUTION...Read More

Company:3M Company – Health Care BusinessDate of Enforcement Report 11/29/2017 Class lI: PRODUCT 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) Recall Number Z-0114-2018 REASON During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to...Read More

CompanySiemens Medical Solutions USA, IncDate of Enforcement Report 11/29/2017 Class lI: PRODUCT Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Recall Number Z-0168-2018 REASON Siemens is releasing a non-medical software application LTA...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 11/22/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Recall Number Z-0102-2018 REASON An undetected shift between the information displayed in the navigation software and the actual...Read More

Company:ICU Medical IncDate of Enforcement Report 11/22/2017 Class lI: PRODUCT Plum 360 Infusion System, List number 30010. Recall Number Z-0101-2018 REASON (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the “Paused” state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be...Read More

Company:Siemens Medical Solutions USA, Inc..Date of Enforcement Report 11/22/2017 Class lI: PRODUCT Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. Serial Number: 2141,...Read More

Company:Siemens Medical Solutions USA, Inc..Date of Enforcement Report 11/22/2017 Class lI: PRODUCT Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. Serial Number: 2136,...Read More

Company:Boston Scientific Corporation.Date of Enforcement Report 11/15/2017 Class lI: PRODUCT RESONATE EL ICD VR, Model D432, Sterile. Recall Number Z-0077-2018 REASON The devices have an incorrect firmware configuration. RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Saint Paul, MN. on 10/4/2017. Voluntary: Firm Initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 5 devices DISTRIBUTION The devices were...Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SF NAV Catheters Model Numbers – BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S Recall Number Z-0058-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters....Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S Recall Number Z-0055-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402...Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S) Recall Number Z-0056-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a...Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S Recall Number Z-0054-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402...Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT HERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter Recall Number Z-0057-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a “Map: magnetic...Read More

Company:Nucletron BV Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-0050-2018 REASON Incorrect...Read More

Company:Beckman Coulter Inc.. Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation. Recall Number Z-0046-2018 REASON Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process,...Read More

Company:Edap Technomed Inc. Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue Recall Number Z-0049-2018 REASON The US FDA has requested the optional energy treatment settings, “medium” and “low” (Software Protocols 02-Medium and 03-Low) be...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Brilliance iCT Xray Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0019-2018 REASON During a bolus tracking...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Brilliance iCT SP Xray Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0020-2018 REASON During a bolus...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0017-2018 REASON During a bolus tracking...Read More

Company:Beckman Coulter Inc.. Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012....Read More

Company:oshiba American Medical Systems Inc Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0016-2018 REASON During a bolus tracking...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0015-2018 REASON During a bolus...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Ingenuity Core128 Xray Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-0018-2018 REASON During a bolus tracking...Read More

Company:Baxter Healthcare CorpDate of Enforcement Report 9/20/2017 ClasslI: PRODUCT Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 Recall Number Z-3133-2017 REASON The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette....Read More

Company:Boston Scientific Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving...Read More

Company: Toshiba American Medical Systems Date of Enforcement Report 9/20/2017 Class lI: PRODUCT Toshiba Medical Radrex – i Digital Radiography X-ray systemRadrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of...Read More

Company:Mako Surgical Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. Recall Number Z-3131-2017 REASON Software discrepancy of not showing all...Read More

Company:Mako Surgical Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. Recall Number Z-3130-2017 REASON Software discrepancy of not showing...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 9/13/2017 Class lI: PRODUCT Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical...Read More

Company:Datascope Corp./MAQUET. Date of Enforcement Report 9/6/2017 Class II: PRODUCT Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. The devices addressed in this communication are the following St. Jude Medical pacemaker and CRT-P devices: Accent, Anthem, Accent MRI, Accent ST, Assurity, Allure...Read More

Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a...Read More