Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report 9/16/2015 Class lI: PRODUCT CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. Recall Number Z-2742-2015 REASON Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and...Read More

Company: Insulet Corporation Date of Enforcement Report: 9/10/2015 Class l: PRODUCT The OmnniPod Insulin Management System is an insulin pump used to deliver insulin to people with diabetes. The insulin pump ?Pod? is a small adhesive pump that sticks directly on the body. Insulin is delivered through a small port holding a tube that is...Read More

/docs/scpred/SoftwareCPR-NewsletterSept2015.pdfRead More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report: 9/9/2015 Class lI: PRODUCT Radiation Therapy Treatment Planning System software 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 treatment, and may be used to administer treatments...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/9/2015 Class lI: PRODUCT Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is 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. Syngo.plaza also supports...Read More

Company: Transonic Systems Inc Date of Enforcement Report 9/9/2015 Class lI: PRODUCT Transonic Flow Probes. Product Usage: to measure flow intra-operatively Reacll number 2720-2729. REASON Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69. RECALLING FIRM/MANUFACTURER Transonic Systems Inc, ithaca, NY on 7/27/2015. Voluntary: Firm Initiated...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 9/9/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD — Ortho Clinical Diagnostics Inc. The VITROS 5,1 FS Chemistry System with enGEN(TM)...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM459917.pdfRead More

Company:Carestream Health Inc.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. Recall Number Z-2449-2015 REASON Carestream became aware of an issue with...Read More

Company:GE Healthcare.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations,...Read More

Company:Medtronic MiniMed Inc..Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management. Recall Number Z-2442-2015 REASON Medtronic MiniMed is recalling...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 9/2/2015 Class lI: PRODUCT Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians. Recall Number Z-2383-2015 REASON The system is designed to emit a...Read More

Company:Nidek Inc.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement...Read More

https://www.softwarecpr.com/feedbackframepage.htmRead More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report: 8/26/2015 Class lI: PRODUCT RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy. Recall Number Z-2457-2015 REASON Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used....Read More

Company:GE Healthcare.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include...Read More

Company:Brainlab AGDate of Enforcement Report: 9/2/2015 Class lI: PRODUCT ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be 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-2440-2015 REASON ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 8/26/2015 Class lI: PRODUCT Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Recall Number Z-2404-2015 REASON in case a system error occurs and the system enters the “Bypass Fluoro”...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 8/26/2015 Class l: PRODUCT Alaris Syringe Pump, Model No. 8110. Delivers fluids. Recall Number Z-2362-2015 REASON Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump...Read More

Company: Covidien LP Date of Enforcement Report 8/262015 Class l: PRODUCT Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). Recall Number Z-2329-2015 REASON Reports...Read More

Company: BIOTRONIK Inc.. Date of Enforcement Report 8/19/2015 Class lI: PRODUCT PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle. Recall Number Z-2376-2015 REASON...Read More

http://www.gpo.gov/fdsys/pkg/FR-2015-08-18/html/2015-20309.htmRead More

Interesting write up: “How Medical Tech Gave a Patient a Massive Overdose”.  The article can be found at https://www.healthleadersmedia.com/innovation/how-medical-tech-gave-patient-massive-overdoseRead More

/docs/FDApremarketclassificationcodexemptionsAug2015.pdfRead More

Company: Philips Electronics North America Corporation Date of Enforcement Report 8/12/2015 Class lI: PRODUCT Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation....Read More

Mylan.Product: ECG Check Application and ECG Check Wireless Lead Cardiac Monitor Date: 8/7/2015 1. Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). 1. Your...Read More

Mylan.Product: pharmaceutical manufacturing facility Date: 8/6/2015 Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel can change master production and control records, or other records (21 CFR 211.68(b)). Your Siemens computer-based BMS and NVPMS do not require passwords to access the network and servers. Your contractors?...Read More

Company: Hamilton Medical. Date of Enforcement Report 8/5/2015 Class lI: PRODUCT Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients. Recall Number Z-2057-2015 REASON Customer reports that the ventilator display can freeze. Ventilation continues but...Read More

Company: Medtronic MiniMed Inc.. Date of Enforcement Report 8/5/2015 Class lI: PRODUCT MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712. Recall Number Z-2260-2015 REASON Medtronic MiniMed is recalling the MiniMed 620G and...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 8/52015 Class lI: PRODUCT ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 8/52015 Class lI: PRODUCT ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems...Read More

Company: McKesson Technologies, Inc. Date of Enforcement Report 8/5/2015 Class lI: PRODUCT Paragon Laboratory Management. Recall Number Z-2263-2015 REASON For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 2012, the Final Cumulative Report may incorrectly display the data. RECALLING FIRM/MANUFACTURER McKesson Technologies, Inc., Charlotte, NC on 6/15/2014. Voluntary: Firm Initiated...Read More

The National Institute of Science of Technology issued Version 1 of its framework for improving cybersecurity for critical infrastructure including health care. The full press release is at the link provided.Read More

FDA issued a safety communication to health care facilities using the Hospira Symbiq Infusion System regarding cybersecurity vulnerabilities. FDA is advising facilities to seek alternative infusion systems. In the interim, it is recommended the systems be disconnected from networks and maintain the drug libraries by updating manually along with other recommendations. An article regarding the...Read More

http://www.consumer.ftc.gov/blog/can-your-app-really-doRead More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. Recall Number Z-2200-2015 REASON Philips, Pinnacle Radiation Treatment Planning System version 9 0, 9 2 9 4, 9 6 is being recalled because the dose may...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2194-2015 REASON Philips has identified four...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2195-2015 REASON Philips has...Read More

Company: Hitachi America, Ltd., Power Systems Division Date of Enforcement Report: 7/29/2015 Class lI: PRODUCT PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachis PROBEAT with DSSS 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: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2196-2015 REASON Philips has...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2198-2015 REASON Philips has identified...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2199-2015 REASON Philips has...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2197-2015 REASON Philips has identified...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2193-2015 REASON Philips has...Read More

Company:Volcano Corporation Date of Enforcement Report: 7/29/2015 Class lI: PRODUCT 1) Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of...Read More

Company:Elekta, Inc. Date of Enforcement Report: 7/22/2015 Class lI: PRODUCT MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-2063-2015 REASON A problem exists in...Read More

Company:Viewray Incorporated Date of Enforcement Report: 7/22/2015 Class lI: PRODUCT Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-2085-2015 REASON ViewRay” received a report that the couch moved unexpectedly into the bore...Read More

Company:Siemens Healthcare Diagnostics, IncDate of Enforcement Report: 7/15/2015 Class lI: PRODUCT Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. Recall Number Z-2054-2015 REASON there is the potential for two software issues to occur in Vista software versions 3.6.1 Issue #1 :Samples stop...Read More

Mahendra Chemicals..Product: pharmaceutical manufacturing facility Date: 7/13/2015 Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data. Your laboratory systems lacked access controls to prevent raw data from being deleted or altered. For example, a) There is no assurance that you maintain complete electronic raw data...Read More

The first amendment to IEC 62304 amendment has been published as Edition 1.1. You can purchase just the amendment, which notates what has changed, or a consolidated redline version. It is currently available from ANSI or IEC. AAMI will publish it in the near future, although it may be expensive to purchase from AAMI. This amendment mainly focuses...Read More