/docs/FDAInfusionPumpLetter042310.pdfRead More

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/docs/FDAInfusionPumpDraftGuidance-042310-UCM209337.pdfRead More

Company: Baxter Healthcare CorpDate of Enforcement Report 4/21//2010 Class:ll PRODUCT Baxter 1550 Single Patient System Hemodialysis Machines; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R. Recall # Z-1322-2010 REASON Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw...Read More

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Company: Ge Healthcare ItcDate of Enforcement Report 4/21//2010 Class:ll PRODUCT 1) GE Centricity PACS-IW software; The intended use: The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations....Read More

Recipient: 3CPM, Inc.Product: electrogastrogram (EGG) devices Date: 325/10 6. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example: b. When requested, no evidence that the changes made to the finished device or...Read More

Company:Picis IncDate of Enforcement Report 4/15//2010 Class:ll PRODUCT CareSuite” – Critical Care Manager, PACU Manager and Anesthesia Manager Software. Recall # Z-1252-2010 REASON Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic...Read More

http://www.massdevice.com/blogs/massdevice/medical-devices-next-hackers-target-listRead More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report 3/31//2010 Class:ll PRODUCT 1) Aplio 50; SSA-700A; software version 5.5r002. Recall # Z-1171-2010; 2) Aplio 80; SSA-770A; software version 5.5r002. Z-1172-2010; 3) Xario; SSA-660A; software version 1.0 and later. Recall # Z-1173-2010 REASON Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A;...Read More

/docs/FDA-IntroToRegulatedSoftwareJMurray0310.pdfRead More

Company:R. O. Golden & Co., IncDate of Enforcement Report 3/24//2010 Class:ll PRODUCT Image Consultant (IC) Software. Recall # Z-1176-2010 REASON Software not validated. RECALLING FIRM/MANUFACTURER Recalling Firm: R. O. Golden & Co., Inc., Elkins Park, PA, by letters on February 5, 2010. Manufacturer: Unique Media, Canton, PA. Firm initiated recall is ongoing. VOLUME OF PRODUCT...Read More

Company:Haemonetics Software SolutionsDate of Enforcement Report 3/24//2010 Class:ll PRODUCT Surround System software. Recall # B-0737-10 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Haemonetics Software Solutions, Rosemont, IL, by e-mail on July 25, 2008. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 35 units DISTRIBUTION DC, FL, HI, IL, IN,...Read More

Company:Beckman Coulter Inc.Date of Enforcement Report 3/17/2010 Class:l PRODUCT 1) Coulter LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean...Read More

CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center’s acceptance of the standard also includes “all collaterals and particulars,” said Herman. She anticipates CDRH will publish a Federal Register...Read More

CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center’s acceptance of the standard also includes “all collaterals and particulars,” said Herman. She anticipates CDRH will publish a Federal Register...Read More

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Attached is a .pdf of a draft guidance from the Chinese medical device regulatory agency (SFDA) that was sent out for comment. SoftwareCPR reviewed and provided a number of comments. It is one of a number of actions by the SFDA indicating movement to more active regulation of medical devices and the software they contain....Read More

Attached is a pdf of the testimony of FDA’s Director of CDRH Jeff Shuren regarding Health Information Technology Policy. It discusses the need for active regulation FDA regulation, the possible approaches to regulation, and the regulatory basis for this. The Appendix provides some examples of adverse events associated with such systems. It identifies four categories:...Read More

Company:Baxter Healthcare Corporation.Date of Enforcement Report 3/4/2010 Class:l PRODUCT Baxter Healthcare Corporation, HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems. These systems have been distributed since 1990 REASON Baxter is conducting a recall of the HomeChoice and HomeChoice PRO because of reports of serious injuries and at least one death associated with increased Intraperitoneal Volume...Read More

Company:Cybernet Systems CorpDate of Enforcement Report 3/3/2010 Class:ll PRODUCT 1) Cybernet Medical MedStar Telemedicine System; Model 533-210. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data...Read More

Company:Remel, Inc.Date of Enforcement Report 3/3//2010 Class:ll PRODUCT ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like, and related organisms isolated from human clinical specimens. A complete listing of...Read More

Company:Sendx Medical IncDate of Enforcement Report 2/17/2010 Class:ll PRODUCT ABL 80 CO-OX System, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX System is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The...Read More

Company:Stryker ImagingDate of Enforcement Report 2/17/2010 Class:ll PRODUCT Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan. Recall # Z-0134-2010 REASON Firm has determined Guardian Services does not contain 100% data backup for...Read More

Company:GE HealthcareDate of Enforcement Report 2/3/2010 Class:ll PRODUCT 1) iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD. Recall # Z-0600-2010; 2) Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2, 13.0, & 13.1....Read More

Company:GE Medical SystemsDate of Enforcement Report 2/3/2010 Class:ll PRODUCT GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages...Read More

On February 20, 2003, a final security rule 45 CFR Part 142 was issued. Subsequently HHS issued a series of educational documents regarding various aspects of the rule including administrative controls, physical controls, technical safeguards, risk management and others.  Read More

Company:GE HealthcareDate of Enforcement Report 2/3/2010 Class:ll PRODUCT 1) GE OEC 9900 Elite ESP, to produce mobile fluoroscopic images of human anatomy. Recall # Z-0004-2010; 2) GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy. Recall # Z-0005-2010 REASON A software defect – may result in a false indication and...Read More

Company:Edwards Lifesciences Inc.br>Date of Enforcement Report 1/11/2010 Class:l PRODUCT Edwards Lifesciences “Aquarius” System; Model Numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The Aquarius monitors the fluid going into and coming out of the patient. Recall # Z-0653-2010 This product was manufactured from July 12, 2007 through March 18, 2009 and distributed...Read More

Company:Philips Healthcare IncDate of Enforcement Report 1/27/2010 Class:ll PRODUCT 1) SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4″display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4″ display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4″...Read More

Company:Hocoma AG,br>Date of Enforcement Report 1/27/2010 Class:ll PRODUCT Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x. Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients. Recall # Z-0590-2010 REASON Changes to the stored “sensitivity” values may occur and leads to higher limits in...Read More

Company:Smiths Medical.ASD Inc.Date of Enforcement Report 1/20/2010 Class:ll PRODUCT 1) Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Recall # Z-0650-2010; 2) Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Recall # Z-0651-2010 REASON Smiths Medical has become aware of an increased trend in...Read More

Company:General Electric Medical Systems Information TechnologyDate of Enforcement Report 1/20/2010 Class:ll PRODUCT GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software). Recall # Z-0631-2010 REASON Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator’s Manual may impact patient safety. When ApexPro...Read More

Company:GE Medical Systems, LLCDate of Enforcement Report 1/13/2010 Class:ll PRODUCT GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems. Recall # Z-0541-2010 REASON GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8...Read More

Company: Sunrise Pharmaceutical, Inc Date: 1/14/10 Product: Pharmaceuticals Your firm has not exercised appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example, your firm lacks systems to ensure that all electronic data generated...Read More

At the link provided is a paper issued in April 2008 by the Australian Department of Defense entitled: “Dependability of Software in Airborne Mission Systems”. It contains a useful list and description of software related standards outside the medical device industry that may be helpful in medical device software development and risk management. AUS SW...Read More

The link provided is for “42 CFR Parts 412, et al. Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule.” 42CFR_412_EHR_HITECHRead More

Company:Draeger Medical, Inc.Date of Enforcement Report 1/6/2010 Class:ll PRODUCT Delta/Delta XL Monitors with Omega S Package. Catalog numbers MS18597 and MS18596. Recall # Z-0582-2010 REASON Monitor is rebooting/resetting. RECALLING FIRM/MANUFACTURER Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter dated November 2009. Manufacturer: Draeger Medical Systems Inc., Danvers, MA. Firm initiated recall is ongoing. VOLUME...Read More

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Company:BioTek Instruments, Inc.Date of Enforcement Report 12/30/2009 Class:ll PRODUCT BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application. Recall # Z-2223-2009 REASON Software design allowed false negatives to be read when wells are dark. RECALLING FIRM/MANUFACTURER...Read More

Company:GE Medical Systems, LLC.Date of Enforcement Report 12/30/2009 Class:ll PRODUCT Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434. Recall # Z-0002-2009 REASON GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that...Read More

Company:GE Healthcare Integrated IT Solutions.Date of Enforcement Report 12/16/2009 Class:ll PRODUCT GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. Recall # Z-0456-2010 REASON There are potential safety issues, including misdiagnosis or delay in...Read More

Company:Cyberonics, Inc.Date of Enforcement Report 12/9/2009 Class:ll PRODUCT Cyberonics VNS Therapy Demipulse Generator Model 250 Programming System, version 4.6, 6.1, 7.0, and 7.1 labeling, for vagus nerve stimulation. Recall # Z-0264-2010 REASON Failure to deliver therapy. Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test...Read More

Company:Picis, Inc.Date of Enforcement Report 12/9/2009 Class:ll PRODUCT PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. Recall # Z-0365-2010 REASON Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between...Read More

Company:Baxter Healthcare Renal DivisionDate of Enforcement Report 12/3/2009 Class:ll PRODUCT System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by...Read More

In the July 2006 IEEE Computer Journal article: “The Power of 10: Rules for Developing Safety- Critical Code” by Gerard J. Holzmann of the NASA/JPL Laboratory for Reliable Software, the following 10 rules were listed: Restrict all code to very simple control flow constructs—do not use go to statements, set jump or long jump constructs,...Read More

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Company:Varian Medical Systems Oncology Systems.Date of Enforcement Report 11/25/2009 Class:ll PRODUCT VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Recall # Z-0133-2010 REASON Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will...Read More

Company:GE Medical Systems Information Tecnology.Date of Enforcement Report 11/18/2009 Class:ll PRODUCT 1) Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients. Recall # Z-1994-2009; 2) Datex-Ohmeda...Read More