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: 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: 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 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: 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: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: 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 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: 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: 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: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: 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: Nihon Kohden America Inc.Date of Enforcement Report: 5/6/2015 Class lI: PRODUCT Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data...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

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 5/6/2015 Class lI: PRODUCT Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and...Read More

Company: Steris CorporationDate of Enforcement Report: 5/6/2015 Class lI: PRODUCT AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities. Recall Number Z-1561-2015 REASON STERIS has identified that the control board software...Read More

Company: Dako North America Inc.Date of Enforcement Report: 5/6/2015 Class lI: PRODUCT Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests...Read More

Company: Optimedica Corporation Date of Enforcement Report: 5/27/2015 Class lI: PRODUCT Catalys Precision Laser System-Catalys – U – US product; Catalys-1 – International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Recall Number Z-1683-2015 REASON Software anomaly on...Read More

Company: Del Mar Reynolds Medical, Ltd.Date of Enforcement Report: 4/29/2015 Class lI: PRODUCT Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia. Recall Number Z-1458-2015 REASON Reports of inaccurate low flow readings. Monitored...Read More

Company:Thermedx LLCDate of Enforcement Report: 4/29/2015 Class lI: PRODUCT Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures. Recall Number Z-1463-2015 REASON To correct software bugs that could affect the ability to accurately measure fluid deficit.....Read More

Company:Baxter Healthcare CorpDate of Enforcement Report: 4/22/2015 Class lI: PRODUCT Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids. Recall...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 4/15/2015 Class lI: PRODUCT ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 4/8/2015 Class lI: PRODUCT Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Recall Number Z-1354-2015 REASON Possibly incomplete archived studies during pre-fetch. In a...Read More