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

Company: Villa Radiology Systems LLC. Date of Enforcement Report 3/18/2015 Class lI: PRODUCT Juno DFR x-ray system Recall Number Z-1079-2015 REASON It has been discovered that the system – does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality RECALLING FIRM/MANUFACTURER Villa Radiology Systems LLC,...Read More

Company:INO Therapeutics (dba Ikaria).Date of Enforcement Report: 3/11/2015 Class lI: PRODUCT Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. Recall Number Z-1223-2015 REASON Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/11/2015 Class lI: PRODUCT Philips Medical System Allura Xper X-Ray Angiographic Recall Number Z-1120-2015 REASON In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Andover, MA 6/6/2014. Voluntary:...Read More

Company: Medtronic MiniMed Inc. Date of Enforcement Report 3/11/2015 Class lII: PRODUCT CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management...Read More

Company:Hospira Inc..Date of Enforcement Report: 5/28/2014 Class l: PRODUCT Plum A+ infusion pumps and Plum A+3 infusion pumps REASON he Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in situations that should trigger it. It is possible for...Read More

Company:Spacelabs Healthcare Inc.Date of Enforcement Report: 3/4/2015 Class lI: PRODUCT Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays,...Read More

Company: GE Healthcare It. Date of Enforcement Report 3/4/2015 Class lI: PRODUCT The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare...Read More

ANSI/AAMI/IEC TIR80001-2-5:2014 “Application of risk management for IT-networks incorporating medical devices Part 2-5: Application guidance: Guidance on distributed alarm systems” has been published. Sherman Eagles of SoftwareCPR was a co-chair for this.Read More

Company:Spacelabs Healthcare Inc.Date of Enforcement Report: 3/4/2015 Class lI: PRODUCT Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393,...Read More

Company:Iba Dosimetry Gmbh.Date of Enforcement Report: 3/4/2015 Class lI: PRODUCT COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological. Recall Number Z-1212-2015 REASON Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or...Read More

Stan Hamilton and Brian Pate of SoftwareCPR offer the following tip. As risk managers, we often struggle to draw the line for inclusion of foreseeable misuse. We ask questions like what is credible, and how far must you go? When performing risk analysis, we decide if it is credible enough to list as a hazard...Read More

/docs/scpred/SoftwareCPR-NewsletterFeb2015.pdfRead More

Novacyl (Thailand), Ltd.Product: active pharmaceutical ingredients (APIs) Date: 2/27/2015 3. Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. The inadequate controls over access to your data raise questions about the authenticity and reliability of your data and the quality of the APIs you produce....Read More

Company:CME America, LLC.Date of Enforcement Report: 2/25/2015 Class lI: PRODUCT BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP Recall Number Z-1126-2015 REASON CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery. RECALLING FIRM/MANUFACTURER CME America, LLC, Golden, CO on 1/16/2015 Voluntary: Firm...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/25/2015 Class lI: PRODUCT Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose...Read More

Company:Alivecor SFO.Date of Enforcement Report: 3/4/2015 Class lI: PRODUCT Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG...Read More

XZeal Technologies, Inc.Product: XZeal Dental X-Ray Unit Z70 Date: 2/20/2015 1. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example: b. Your firm has not established and maintained documentation in support of Section 4.6 – Design Validation of the Product – Conception and Development, PR0-04.01,...Read More

Inovo, IncProduct: AccuPulse Model 6505 oxygen conserver, Bonsai Velocity oxygen conserver, Evolution oxygen conserver, Evolution with Motion oxygen conserver, SmartDose oxygen conserver, Smart Does Mini oxygen conserver, Oxymizer Disposable oxygen conservers, and oxygen Regulators. Date: 2/19/2015 4. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,...Read More

Company: Natus Medical Incorporated Date of Enforcement Report 2/18/2015 Class lI: PRODUCT Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to...Read More

Company:TeraRecon, Inc.Date of Enforcement Report: 2/18/2015 Class lI: PRODUCT Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and visualization functions, including basic features and advanced post processing modules. The system can be configured...Read More

Company: Natus Medical Incorporated Date of Enforcement Report 2/18/2015 Class lI: PRODUCT EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. Recall Number Z-1068-2015 REASON Software error occurs when using remote monitoring;...Read More

Company:SCC Soft ComputerDate of Enforcement Report: 2/18/2015 Class lI: PRODUCT SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0 Recall Number Z-1065-2015 REASON Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report,...Read More

The International Medical Device Regulators Forum (IMDRF) in which FDA participates continues to publish many documents including several related to software.Read More

Company:SCC Soft ComputerDate of Enforcement Report: 2/11/2015 Class lI: PRODUCT SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory. Recall Number Z-1038-2015 REASON The interface fails to send abnormal flags for Reference Lab test results. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL...Read More

Company: Carl Zeiss Meditec AG Date of Enforcement Report 2/11/2015 Class lI: PRODUCT FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928...Read More

Company: Annimas Corp. Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. Recall Number Z-1034-2015 REASON ICalibration factors in the pump overwritten during a programming step. The force sensor...Read More

Company: Covidien LP (formerly Nellcor Puritan Bennett Inc.) Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of...Read More

Company:Radiometer America IncDate of Enforcement Report: 2/11/2015 Class lI: PRODUCT ABL90 FLEX analyzer, Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. Recall Number Z-1046-2015 REASON The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This...Read More

Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report 2/11/2015 Class lI: PRODUCT Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment. Recall Number Z-1047-2015 REASON Potential for misinterpretation of...Read More

FDA issued a revision to its “Mobile Medical Applications” Guidance Feb 9, 2015. The revision was to make this guidance consistent with the final “Medical Image Storage Devices, and Medical Image Communications Devices” guidance. Specific changes are FDA’s exercising of enforcement discretion to exempt MDDS and some Mobile Medical Apps from compliance the FDA regualtion....Read More

docs/scpred/SoftwareCPR-NewsletterFeb2015.pdfRead More

The Federal Advisory Committee calendar of meetings is at the link provided. Attendance or downloading of material for most of these meetings is open to the public.Read More

HIT Implementation, Usability and Safety Workgroup meeting on Friday, February 6, 2015 – SoftwareCPR® Partners Sherman Eagles and Alan Kusinitz gave a presentation at ONC’s request with recommendations on an approach to HealthIT provider quality systems regulation and standards. In addition to providing background on quality systems, SoftwareCPR® recommended that a standard or guidance be...Read More

FDA issued a final version of its guidance for “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The document is dated February 9, 2015, although it was issued several days prior. This guidance is very significant as it states FDA is exercising discretion and not requiring compliance to the recent...Read More

Company:GE Healthcare Date of Enforcement Report 2/4/2015 Class lI: PRODUCT The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. Recall Number...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 2/4/2015 Class lI: PRODUCT BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging Recall Number Z-1011-2015 REASON Unintended detector and gantry movement due to software issues. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc.,Cleveland, OH 11/12/2014. Voluntary:...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 2/4/2015 Class lI: PRODUCT Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the...Read More

Company: INNOKAS MEDICAL OY. Date of Enforcement Report 2/4/2015 Class lI: PRODUCT VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014. Recall Number Z-1022-2015 REASON If the SpO2 or RRa value is violating the respective alarm...Read More

AAMI has filed a Project Initiation Notice with ANSI for a new standard on Application of Quality Management Principles and Practices to Health IT. The notice was published in the ANSI Standards Action publication on January 23. The notice is reproduced below. BSR/AAMI HIT2000-201x, Application of Quality Management Principles and Practices to Health IT Stakeholders:...Read More

AAMI has filed a Project Initiation Notice with ANSI for a new standard on Application of Quality Management Principles and Practices to Health IT. The notice was published in the ANSI Standards Action publication on January 23. The notice is reproduced below. BSR/AAMI HIT2000-201x, Application of Quality Management Principles and Practices to Health IT (new...Read More

A committee draft (CD) of “IEC TR 62366-2: Medical devices – Part 2: Guidance on the application of usability engineering to medical devices” was issued for comment. This technical report provides medical device manufacturers with guidance on how to integrate usability engineering (also called human factors engineering) principles and user interface design practices into their...Read More

Company:Maquet Medical Systems USADate of Enforcement Report: 1/28/2015 Class lI: PRODUCT TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the cental operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/28/2015 Class lI: PRODUCT VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 – in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 – in vitro quantitative, semi-quantitative, and qualitative...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 1/28/2015 Class lI: PRODUCT Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull,...Read More

FDA added the following standards to their recognized standards list and published the new recognitions January 2015. IEC TR 80001-2-5 2014. Application of risk management for IT networks incorporating medical devices–Part 2-5: Application guidance–Guidance on distributed alarm systems. IEEE Std 11073-10425- Health informatics 2014. Personal health device comunication, Part 10425: Device Specialization–Continuous Glucose Monitor (CGM)....Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD — Ortho Clinical Diagnostics. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products...Read More

Company:Phadia US IncDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing,...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT VITROS 5600 Integrated System, Catalog Number 6802413, IVD — Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents....Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 1/21/2015 Class lI: PRODUCT VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD — Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. Recall Number Z-0967-2015 REASON Software Anomaly: the firm has identified...Read More