IEC 60601-1 only applies to medical electrical equipment. So software that is a stand alone product does not fall within the scope of IEC 60601-1. A new work item on Healthcare Software Systems was recently approved. This new standard is intended to apply to stand alone software and will have similar (but not necessarily the...Read More

Company: AGFA Corp.Date of Enforcement Report 3/23/2011 Class ll: PRODUCT IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8; Catalog Number CM 60+ 00091915. Recall # Z-1676-2011 REASON A discrepancy in the validation testing which resulted in the product not performing as intended. RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by...Read More

There is a specific standard for radiotherapy treatment planning systems, IEC 62083 Edition 2.0 (2009-09-23) Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems. When there is a specific standard, it takes precedent over general standards. IEC 60601-1 only applies to medical electrical equipment. So software that is a stand alone...Read More

FDA issued a new list of recognized standards. This includes withdrawal of recognition of the previous version and recognition of: “12-218 NEMA PS 3.1–3.18 Withdrawn and replaced with newer version (2009) Digital Imaging and Communications in Medicine (DICOM) Set.”Read More

MASSDEVICE reported that “At a Food & Drug Administration town hall meeting held March 10 in Irving, Texas, Center for Devices and Radiological Health director Dr. Jeffrey Shuren disclosed … that the agency plans to issue guidance on mobile medical applications later this year.”Read More

Company: AGFA Corp.Date of Enforcement Report 3/9/2011 Class ll: PRODUCT IMPAX CV Results Manager/Results Manager Administration Tool. The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows...Read More

Company: Bio-Rad Laboratories Inc.Date of Enforcement Report 3/9/2011 Class ll: PRODUCT PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via Ethernet hub. The computer provides work list generation, data...Read More

Company: Stryker Instruments Division of Stryker Corp.Date of Enforcement Report 3/2/2011 PRODUCT 1) Stryker Navigation System – iNtellect Cranial Software, Part number 6000-650-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization...Read More

Company: Toshiba American Medical Systems IncDate of Enforcement Report 2/23/2011 Class ll: PRODUCT Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) – Whole Body X-Ray CT Scanner. Recall # Z-1257-2011 REASON Incorrect Dose Calculation. The software that performs the pre-scan dose calculation uses an incorrect parameter for an exam Plan using a tube voltage of 80kV or 100kV....Read More

Company: GE Healthcare ITDate of Enforcement Report 2/23/2011 Class ll: PRODUCT GE Centricity Laboratory software; The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. The Centricity Laboratory software is used to...Read More

Company: Hill Rom Inc.Date of Enforcement Report 2/16/2011 Class ll: PRODUCT 1) Hill-Rom TotalCare Bed, P1900. The TotalCare Bed System is intended to provide patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including but not limited to, acute care, including...Read More

Company: Abbott Point of Care Inc.Date of Enforcement Report 2/9/2011 Class ll: PRODUCT i-STAT Level 2 Control Value Assignment Sheets Human Consumption. a) Abbott List Number: 06F13-01; b) Abbott List Number: 025715. Recall # Z-1020-2011. REASON Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain...Read More

Company: Philips Healthcare Inc.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03. Recall # Z-0414-2011. REASON Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions...Read More

Company: Impac Medical Systems Inc., .Date of Enforcement Report 2/9/2011 Class ll: PRODUCT SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment...Read More

Company: Impac Medical Systems Inc., .Date of Enforcement Report 2/9/2011 Class ll: PRODUCT SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control. Recall # Z-1029-2011. REASON Computer interface is defected. Computer based verification system...Read More

Company:Images, Inc., Date of Enforcement Report 2/9/2011 Class ll: PRODUCT Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect...Read More

Company: Radiometer America Inc. Date of Enforcement Report 2/9/2011 Class ll: PRODUCT ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood. Recall #...Read More

Company: Teco Diagnostics.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT 1) Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses...Read More

Company: Varian Medical Systems.Date of Enforcement Report 1/26/2011 Class ll: PRODUCT Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System. Recall Z-0911-2011 REASON Possible incorrect dose calculation: An anomaly in certain Eclipse versions where, under certain specific sequences of user...Read More

Company: Vital Images Inc.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT...Read More

Company: Philips Healthcare Inc.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. The intended use of the Information Center Software is...Read More

Company: GE Healthcare, LLC.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT GE Healthcare Transport Pro Monitor with the CARESCAPE” Patient Data Module. Recall # Z-0363-2011. REASON Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time...Read More

Company: Accuray Inc..Date of Enforcement Report 2/9/2011 Class ll: PRODUCT Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the...Read More

Company: Accuray Inc.Date of Enforcement Report 2/9/2011 Class ll: PRODUCT CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body...Read More

Company: Varian Medical SystemsDate of Enforcement Report 2/2/2011 Class ll: PRODUCT 4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while...Read More

Risk/hazard analysis for medical devices and their software require extensive analysis, documentation, and maintenance of complex information. Creation and maintenance of extensive tables, fault tree, and HAZOP diagrams can seem overwhelming. For complex and high risk systems the information can be voluminous and software tools can be very productive. Trace tools such as DOORS, CALIBER-RM,...Read More

Company: B. Braun Medical, Inc Date of Enforcement Report 1/24/2010 Class l: PRODUCT Outlook 400ES Safety Infusion System Model number 621-400ES Manufacturing From: May 21, 2009 – June 23, 2009 Distribution From: July, 24, 2009 – December 31, 2009 The recalled products were upgraded from May 4, 2010 – June 21, 2010. Use: The B....Read More

Company: Varian Medical Systems Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Medical Systems Inc., Palo Alto, CA Intended use: The 4D Integrated Treatment Console function is...Read More

Company: McKesson Provider Technologies .Date of Enforcement Report 1/19/2011 Class ll: PRODUCT Horizon Cardiology ECG Management This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and...Read More

Company: GE Healthcare.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 1) HiSpeed LXI (2200997). Recall # Z-0744-2011; 2) HiSpeed LX/l (2200997-2). Recall # Z-0745-2011; 3) HiSpeed DX/I (2201000). Z-0746-2011; 4) HiSpeed DX/I (2201000-2). Recall # Z-0747-2011; 5) HiSpeed DX/I (2249696). Recall # Z-0768-2011; 6) HiSpeed DX/I (2249696-2). Recall # Z-0770-2011; 7) HiSpeed FX/I (2200997 with...Read More

Company: Varian Medical Systems Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX. The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and...Read More

Company: C. R. Bard Inc.Date of Enforcement Report 1/19/2011 Class lll: PRODUCT Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter. Recall # Z-0719-2011 REASON Error can occur...Read More

Company: Bunnell Inc.Date of Enforcement Report 1/19/2011 Class ll: PRODUCT 1) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Rx Only. Recall # Z-0901-2011; 2) One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203, Rx Only. Recall # Z-0902-2011 REASON Product software coding error may compromise patient safety. RECALLING FIRM/MANUFACTURER Bunnell, Inc.,...Read More

Recipient: Verichem Laboratories Inc.Product: clinical chemistry reference materials for in-vitro diagnostic (IVD) use Date: 12/16/10 1. Failure to validate the design under defined operating conditions and by using initial production units, lots, batches, or their equivalents, as required by 21 CFR 820.30(g). b) Your firm failed to perform design validation for the data analysis software...Read More

Company: GE Medical Systems.Date of Enforcement Report 12/22/2010 Class ll: PRODUCT Signa Excite” 1.5 T Magnetic Resonance Systems. Recall # Z-0462-2011p> REASON Signa? MR Excite” 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience an image flip...Read More

Company: SCC Soft Computer..Date of Enforcement Report 12/22/2010 Class ll: PRODUCT SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports. 23.1:BK040048 23.2:BK080020 25.0:BK090017 The SoftBank II application, using SoftScape user interface, is a decision support software device that requires knowledgeable user intervention to document steps and events in a transfusion service. The application provides single and...Read More

Company: Philips Medical SystemsDate of Enforcement Report 12/22/2010 Class ll: PRODUCT Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or...Read More

Company: SCC Soft Computer..Date of Enforcement Report 12/22/2010 Class ll: PRODUCT SoftLab GUI Version 4.0.1.0 – 4.0.1.16, 4.0.2.0 – 4.0.2.10, 4.0.3.0 – 4.0.3.13, and 4.0.4.0 – 4.0.4.5. Manufacture/Distribution Dates: 4.0.1.0 – 08/06/04, 4.0.1.4 – 10/18/04, 4.0.1.5 – 01/18/04, 4.0.1.6 – 12/15/04, 4.0.1.7 – 01/10/05, 4.0.1.8 – 03/29/05, 4.0.1.9 – 05/06/05, 4.0.1.13 – 01/25/06, 4.0.1.14 –...Read More

Company: SCC Soft Computer.Date of Enforcement Report 12/22/2010 Class l: PRODUCT SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel. Recall # Z-0344-2011...Read More

Company: SonoSite.Date of Enforcement Report 12/22/2010 Class lll: PRODUCT The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system. Part code: P11111-35. Recall # Z-0478-2011 REASON Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the...Read More

Company: GE Healthcare, LLC.Date of Enforcement Report 12/22/2010 Class ll: PRODUCT 1) GE LightSpeed VCT Scanner System, models: a) 5212920-300, b) 5212920-310, c) 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. Is intended to produce...Read More

Company: Smith & NephewDate of Enforcement Report 12/22/2010 Class ll: PRODUCT Smith & Nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation....Read More

Recipient:Cincinnati Sub-Zero Products, Inc. Product:Blanketrol II, Blanketrol III, Electri-Cool II, Micro-Temp LT, Hemotherm, Norm-O-Temp, Extra Corporeal Membrane Oxygenation Blood Temperature Control System, and Warm Air Hyperthermia System Date:12/13/2010 Failure to establish and maintain adequate procedures for validating the device design, including software, to ensure that devices conform to user needs and intended uses and include...Read More

Company: Hospira, Inc.Date of Enforcement Report: 12/8/2010 Class ll: PRODUCT EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5. Recall # Z-0126-2011 REASON The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin. RECALLING FIRM/MANUFACTURER Recalling...Read More

Company: CareFusion Corp..Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module. Recall # Z-0492-2011 REASON Issue: PC Unit model 8000, when used with Pump or Syringe modules, may under certain conditions display an incorrect total dose when programmed to deliver...Read More

Company:Philips Medical Systems Date of Enforcement Report 12/8/2010 Class ll: PRODUCT 1) Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems. Recall # Z-0124-2011;...Read More

Company:Volcano Corp., Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology. Recall # Z-0168-2011 REASON Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification...Read More

Company: Philips Healthcare.Date of Enforcement Report 12/8/2010 Class ll: PRODUCT Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-0133-2011 REASON Philips Healthcare has decided to recall the Computed Tomography X-Ray System...Read More

Company:Instrumentation Laboratory Co.Date of Enforcement Report 12/8/2010 Class ll: PRODUCT 1) ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis...Read More

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