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: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: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: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: 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

Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into...Read More

Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery Recall Number Z-3050-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that...Read More

Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery. Recall Number Z-3049-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error...Read More

Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...Read More

Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...Read More

Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...Read More

Company:Soft Computer Consultants, Inc.Date of Enforcement Report 8/9/2017 ClasslI: PRODUCT SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, Recall Number Z-2865-2017 REASON Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent...Read More

Company:Beckman Coulter Inc.. Date of Enforcement Report 8/2/2017 Class lII: PRODUCT Beckman Coulter PK7300(R) Automated Microplate System, Catalogue Numbers: N3209000 and N2007600y Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number B-0741-2017 REASON Beckman Coulter’s PK7300, associated with a defect or glitch with the dispensing monitoring board, was distributed.. RECALLING FIRM/MANUFACTURER Bedkman Coulter, Brea, CA...Read More

Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 Class lI: PRODUCT CS 100i Intra-Aortic Balloon Pump. Recall Number Z-2736-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a...Read More

Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 ClasslI: PRODUCT CS 300 Intra-Aortic Balloon Pump Recall Number Z-2738-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient...Read More

Company:Draegar Medical Systems, Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number Z-2734-2017 REASON Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.. RECALLING FIRM/MANUFACTURER Draegar...Read More

Company:AGFA Healthcare Corp. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Agfa Healthcare NX 3.0.8950 Imaging Processing Software Recall Number Z-2735-2017 REASON A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and...Read More

Company:Medtronic Navigation Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Recall Number Z-2746-2017 REASON Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server...Read More

Company: CardioTek BV. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. Recall Number Z-2657-2017 REASON Software bug which allows parameters to be changed unintentionally...Read More

Company: Ion Beam Applications S.A.. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System – Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation....Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 7/12/2017 Class lI: PRODUCT Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 — Programmable diagnostic computer, Recall Number Z-2688-2017 REASON Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/...Read More

Company:CareFusion 303, Inc. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT Alaris PC Unit, Model 8015 Recall Number Z-2671-2017 REASON BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions. RECALLING...Read More

Company: AGFA Healthcare Corp.. Date of Enforcement Report 7/5/2017 Class lI: PRODUCT IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats Recall Number Z-2652-2017 REASON A customer experienced when...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 7/5/2017 Class lI: PRODUCT Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are...Read More

FDA CDRHLearn released a new tutorial entitled ‘Electronic Submission of 806 Reports of Corrections and Removals”. The full tutorial is at the link provided. FDA Tutorial E-submission of 806 reportsRead More

Company: Merge Healthcare, Inc. Date of Enforcement Report 6/21/2017 Class lI: PRODUCT Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography Recall Number Z-2591-2017 REASON Merge PACS did not show unviewed images when the last...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 6/21/2017 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-2590-2017 REASON Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because...Read More

Company: Nexstim PLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of...Read More

Company: Circadiance LLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients Recall Number Z-2250-2017 REASON Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to...Read More

Company: Nexstim PLC Date of Enforcement Report 6/14/2017 Class lI: PRODUCT Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. Recall Number Z-2319-2017 REASON Software defect: the NBS software may...Read More

Company: Toshiba American Medical Systems Inc Date of Enforcement Report 6/7/2017 Class lI: PRODUCT Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F Recall Number Z-2109-2017 REASON It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 5/31/2017 Class lI: PRODUCT Merge Cardio software Recall Number Z-2123-2017 REASON Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother’s MRN, resulting in the wrong fetal measurements getting referenced. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc.,...Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 5/31/2017 Class lI: PRODUCT AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.. Recall Number Z-2156-2017 REASON An extremely dusty computer can cause problems at system start, or rarely, cause system fail....Read More

Company: Ion Beam Applications S.A .Date of Enforcement Report 5/24/2017 Class lI: PRODUCT Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Recall Number Z-2097-2017 REASON A PBS (Pencil...Read More

Company: Magellan Diagnostics Inc. Date of Enforcement Report: 5/24/2017 Class I: PRODUCT Magellan Diagnostics Inc. Recalls LeadCare Plus and Ultra Testing Systems Due to Inaccurate Test Results. The LeadCare Plus and the LeadCare Ultra Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a...Read More

Company: Mobius Medical Systems, LP Date of Enforcement Report 5/24/2017 Class lI: PRODUCT Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially...Read More

Company: Ortho-Clinical Diagnostics. Date of Enforcement Report 5/24/2017 Class lI: PRODUCT enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD Recall Number Z-2077-2017 REASON Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the...Read More

Company: Abbott-Thoratec Date of Enforcement Report 5/23/2017 Class I: PRODUCT HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller The Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system, a mechanical device that circulates...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 5/10/2017 Class lI: PRODUCT AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser,...Read More