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

The ballot on the final draft of the IEC 62304 amendment, which focuses on safety classification and legacy software, closes in May. We expect publication by July, followed by a consolidated version that incorporates the amendment. Adoption by CENELEC as an EN is happening concurrently, so harmonization by the EU should happen late this year...Read More

The International Medical Device Regulators Forum (IMDRF) SaMD draft of a quality system for Software as a Medical Device is available for public comment.Read More

Link updated December 2018. In November 2014, Health Canada began requiring electronic submissions of license applications for Class III and Class IV medical Devices entitled: “Guidance for Industry: Formatting of Class III and Class IV Licence Applications (Electronic and Paper Formats)” File # 14-112992-741. Certain types of CDs and DVDs are specified along with information...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: 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: 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

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: 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

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: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: 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: 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: 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: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: 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: 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: 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: 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

Hospira Lifecare PCA infusion pump running “SW ver 412” does not require authentication for Telnet sessions, which allows remote attackers to gain root privileges via TCP port 23.  The U.S. Department of Homeland Security has been working with Hospira to get this resolved and Hospira will be performing a recall to correct this.Read More

Soft Computer Consultants, Inc.Product: Class I/II software systems Date: 4/30/2015 1. Failure to adequately establish procedures for CAPA as required by 21 CFR 820.100(a). Specifically, A. Product Change Controls (PCCs) which are corrective and preventive actions for handling software coding defects do not always include investigating the cause of all nonconformities relating to product, processes...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

SoftwareCPR® is pleased to announce their Silver Service partnership with Ranorex®, an excellent test automation tool and company.  You can read other posts on our site regarding Ranorex® here. As a silver partner, SoftwareCPR® is recognized as having the quality and experience needed for developing automated tests using Ranorex®, both in regulated and non-regulated environments....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

AAMI published an article entitled: “Best Practices in Applying Medical Device Risk Management Terminology” in its Spring 2015 Horizons publication. Alan Kusinitz, Founder of SoftwareCPR, co-authored this article and a reprint is provided with the permission of AAMI at the link provided. This is for your personal reference not for wider distribution due to the...Read More

Quality Electrodynamics, LLC..Product: cois used in conjunction with MRI scanners . Date: 4/10/2015 Failure to document validation activities, as required by 21 CFR 820.75(a). Specifically, The setting (temperature and line speed) used during the validation studies for the reflow oven, which is part of the SMT (Surface Mount Technology) line, to determine the optimum settings...Read More

Crisis Prevention and Recovery, LLC (CPR) is excited to announce the formation of a new business speciality, HumanFactorsCPR. HumanFactorsCPR is the fourth business speciality under the CPR brand, joining SoftwareCPR, ValidationCPR, and RegulatoryCPR. “One of the most attractive features of our new HumanFactorsCPR services is our capability to bridge the risk analysis process with the...Read More

Company:Roche Diabetes Care, Inc.Date of Enforcement Report: 4/8/2015 Class lI: PRODUCT ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management. Recall Number Z-1369-2015 REASON Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/8/2015 Class lI: PRODUCT Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH Recall Number Z-1359-2015 REASON Philips discovered that a software defect exists in marketed product wherein the...Read More

http://www.ecri.org/press/Pages/Alarms-Health-IT-Patient-Violence-2015-Top-10-Patient-Safety-Concerns.aspxRead 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

Recipient: Yunnan Hande Bio-Tech. Co. Ltd..Product: active pharmaceutical ingredients . Date: 4/6/2015 Our investigators observed specific deviations during the inspection, including, but not limited to, the following: 1. Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. You lacked controls to prevent the unauthorized manipulation...Read More

Company:CareFusion 303, Inc.Date of Enforcement Report: 4/1/2015 Class lI: PRODUCT Alaris PC units, Model No. 8015. Infusion pump. Recall Number Z-1311-2015 REASON CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the “Power-On Self Test” due to a keypad issue. RECALLING FIRM/MANUFACTURER CareFusion...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 4/1/2015 Class lI: PRODUCT MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body,...Read More

Company:GE Healthcare Date of Enforcement Report: 4/1/2015 Class lI: PRODUCT GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour,...Read More

Company:Brainlab AGDate of Enforcement Report: 4/1/2015 Class lI: PRODUCT ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. Recall Number Z-1316-2015 REASON The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.. RECALLING FIRM/MANUFACTURER...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report: 4/1/2015 Class lI: PRODUCT RayStation Radiation Therapy Treatment Planning System; — RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation...Read More

The Joint Commission, the nation’s largest accreditation organization for hospitals offers a free one hour online course entitled “Investigating and Preventing Health Information Technology-Related Patient Safety Events” at the link provided. https://www.jointcommission.org/topics/free_online_education_courses.aspxRead More

/docs/TJCSafetyAlert54.pdfRead More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 3/25/2015 Class lI: PRODUCT ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number Z-0984-2015 REASON There may be an existing dark current phenomenon on...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 3/25/2015 Class lI: PRODUCT Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories Recall Number Z-1282-2015 REASON There is a potential safety risk when using LANTIS server software with operating systems with which it...Read More

Company:St Jude Medical.Date of Enforcement Report: 3/25/2015 Class lI: PRODUCT TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrophysiological mapping and for...Read More

Company:Mindray DS USA, Inc. dba Mindray North AmericaDate of Enforcement Report: 3/25/2015 Class lI: PRODUCT VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. Recall Number Z-1280-2015 REASON...Read More

/Docs/2015-ONCHITCertificationCriteriaPrePubVersion06612.pdfRead More

The draft of the US ONC proposed 2015 HealthIT ceritfication requirements rule is at the link provided. The final will be published March 30, 2015. This new version requires use of a quality system and states: “….QMS established by the federal government and SDOs include FDA’s quality system regulation in 21 CFR part 820, ISO...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 3/18/2015 Class lI: PRODUCT VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITROS Analyzer Systems. Recall Number Z-1263-2015 REASON...Read More