Company: CareFusion 303, Inc. Date of Enforcement Report 7/2/2015 Class l: PRODUCT A syringe pump is a small infusion pump that delivers fluids, such as nutrients and medications, into a patient?s body in controlled amounts. They are widely used in clinical settings such as hospitals, nursing homes, and in the home.. REASON An error in...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/1/2015 Class lI: PRODUCT Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro...Read More

Company: New Star Lasers, Inc. Date of Enforcement Report: June 27, 2015 Class II PRODUCT StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. Recall Number:...Read More

Company: Mortara Instrument, Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit. Recall Number Z-1811-2015 REASON CareFusion...Read More

Company: Philips Ultrasound Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis...Read More

Company: Boston Scientific Corporation Date of Enforcement Report 6/24/2015 Class lI: PRODUCT CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 – 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. Recall Number Z-1742-2015 REASON Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected...Read More

Company: Elekta Inc. Date of Enforcement Report 6/17/2015 Class lI: PRODUCT Leksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment. Recall Number Z-1719-2015 REASON Memory can become corrupted when creating a fused study via drag & drop in Leksell GammaPlan 10.2. RECALLING FIRM/MANUFACTURER Elekta Inc.,...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing.Recall Z-1728-2015 REASON Software anomaly...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing Recall...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. Recall Number Z-1743-2015 REASON Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/10/2015 Class lI: PRODUCT Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Recall Number Z-1705-2015 REASON measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency...Read More

Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area....Read More

Company: Medtronic Neuromodulation Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. Recall Number...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems 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-1647-2015 REASON The firm was informed that while raising the patient...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 10 Air. Computed Tomography X-ray systems 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-1654-2015 REASON The firm was informed that while raising the patient...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance iCT. Computed Tomography X-ray systems 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-1656-2015 REASON The firm was informed that while raising the patient couch on...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 16 Power. Computed Tomography X-ray systems 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-1651-2015 REASON The firm was informed that while raising the patient...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 40. Computed Tomography X-ray systems 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-1650-2015 REASON The firm was informed that while raising the patient couch...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Ingenuity CT. Computed Tomography X-ray systems 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-1657-2015 REASON The firm was informed that while raising the patient couch on...Read More

Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation 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...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 6 Air. Computed Tomography X-ray systems 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-1655-2015 REASON The firm was informed that while raising the patient...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 64. Computed Tomography X-ray systems 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-1649-2015 REASON The firm was informed that while raising the patient couch...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also...Read More

Company: Elekta Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Oncentra Brachy 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-1712-2015 REASON Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. RECALLING FIRM/MANUFACTURER...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems 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-1648-2015 REASON The firm was informed that while raising the...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. Recall Number...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 5/27/2015 Class lI: PRODUCT Philips Healthcare DigitalDiagnost System X-Ray Recall Number Z-1554-2015 REASON The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 5/27/2015 Class lI: PRODUCT Philips Healthcare DuraDiagnost X- Ray Recall Number Z-1555-2015 REASON The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal....Read More

Company: Philips Ultrasound, Inc..Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1)...Read More

Company: Baxter Corporation Englewood Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing. Recall Number Z-1628-2015 REASON Baxter Corporation is conducting a field action for...Read More

Company: Philips Ultrasound, Inc..Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591...Read More

Company: Philips Ultrasound, Inc..Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591 (1.2.2) 453561785101 (1.3) 453561800601 (1.3.1)...Read More

Company: Spacelabs Healthcare IncDate of Enforcement Report: 5/13/2015 Class lI: PRODUCT Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any...Read More

FDA issued a Medwatch alert for infusion pumps May 13, 2015, regarding security vulnerabilities in Hospira’s LifeCare PCA3 and PCA5 Infusion Pump Systems.  A researcher has shown that exploiting the vulnerabilities could allow an unauthorized user to remotely modify the dosage delivered.  Homeland security was previously working with Hospira about this vulnerability (we reported on...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative...Read More

Company: Eos Imaging Inc.Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT EOS, Digital radiography system used in general radiographic examinations. Recall Number Z-1460-2015 REASON When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with...Read More

Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK.Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) Recall Number Z-1574-2015 REASON The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment...Read More

Company:Stryker Instruments Div. of Stryker Corporation.Date of Enforcement Report: 5/13/2015 Class lII: PRODUCT Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece...Read More

Company: ViewRay Inc.Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT ViewRay System, Radiation Therapy System Recall Number Z-1580-2015 REASON The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error. RECALLING FIRM/MANUFACTURER ViewRay Inc, Oakwood Village,...Read More

Company: Philips Ultrasound, Inc..Date of Enforcement Report: 5/13/2015 Class lI: PRODUCT EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1) 453561805181 (1.3.2) Recall Number...Read More

Company:Brainlab AGDate of Enforcement Report: 5/13/2015 Class lI: PRODUCT ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Recall Number Z-1582-2015 REASON ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam...Read More

Company: Spacelabs Healthcare IncDate of Enforcement Report: 5/6/2015 Class lI: PRODUCT Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in...Read More

Company: Lumenis Limited.Date of Enforcement Report: 5/6/2015 Class lI: PRODUCT Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. Recall Number Z-1519-2015 REASON Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair...Read More