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Company: Naviscan PET Systems Date of Enforcement Report:10/17/2007 Class:lll PRODUCT PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging, Recall # Z-0041-2008 REASON Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired...
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The new revision of ISO 14971 was released in 2007 and is now a harmonized standard in the EU. The transition period for companies using the previous version ends March 9, 2010.
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The draft AAMI Technical Information Report “Validation of software for regulated processes” has completed balloting. This document addresses software used to automate production and quality systems. The working group is resolving comments submitted and the timeline for release is Q1 2008.
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Microsoft announced they have a fix for a bug that causes display of 100,000 when the actual number is 2 to the 65,536. Even with validation this would be difficult to catch in testing unless one happened to pick test cases that included values resulting in exactly 65,536 or 65,535 Information related to this is...
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http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html#2
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Company:Philips Nuclear Medicine, Inc., Date of Enforcement Report:10/3/2007 Class:ll PRODUCT The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating...
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Company:Baxa Corporation, IncDate of Enforcement Report:10/3/2007 Class:l PRODUCT Exacta-Mix 2400 OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Recall # Z-1238-2007 REASON A software defect could allow up to 50mL of extra volume being added to a TPN (Total Parenteral Nutrition) solution. RECALLING FIRM/MANUFACTURER Baxa Corporation, Englewood, CO, by telephone and letter on June 27,...
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Company:Cerner Corp.Date of Enforcement Report:10/3/2007 Class:ll PRODUCT Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities Recall # Z-1243-2007 REASON Defects in the Auto Launch functionality make it possible for a mismatch of patient data. RECALLING FIRM/MANUFACTURER Cerner Corp., Kansas City, MO, by telephone on August 23, 2007 and by letters dated...
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Company:Roche Molecular Systems, IncDate of Enforcement Report:10/3/2007 Class:ll PRODUCT Ampilink Software versions 1.1, 1.3, 1.4, 2.41 and 2.42 [COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor v1.5 test; COBAS Amplicor HIV-1 Monitor test v1.5; COBAS AmpliScreen HBV Test; COBAS AmpliScreen HCV Test, version 2; COBAS AmpliScreen HIV-1 Test, version 1.5], Recall # B-1554-07 REASON For select COBAS AMPLICOR...
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Company:Intuitive Surgical, Inc., Date of Enforcement Report:10/3/2007 Class:ll PRODUCT Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Recall # Z-1244-2007 REASON Under certain circumstances, the product’s software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual...
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Company:Misys Encompass Versions 2.2.1, 2.3 and 2.4sDate of Enforcement Report:10/3/2007 Class:ll PRODUCT Misys Encompass Versions 2.2.1, 2.3 and 2.4, Recall # B-1557-07 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, by e-mail on April 16, 2007. Firm initiated recall is ongoing.. VOLUME OF...
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The EU parliament released a final revision of the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). It includes a number of additions related to software. These additions and clarifications stress that standalone software can be a medical device but not all software used in healthcare is a medical device. It also...
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The new version of IEC 60601-1 (3rd edition, 2005) replaces IEC 60601-1-4, not just ISO 14971. IEC 60601-1-4 includes both risk management requirements and PEMS development process requirements. IEC 60601-1-4 remains a harmonized standard in the EU to meet the essential requirement of the MDD on PEMS, if the 2nd edition of IEC 60601-1 is...
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The US Department of Homeland Security (DHS) released software security information via a webpage, initiatives, and various documents related to software security. Some of this information (such as the paper on Security in a Software Lifecycle) may aid medical device IT and device software developers in designing in appropriate security and privacy measures to ensure...
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Company:Sendx Medical IncDate of Enforcement Report:9.5/2007 Class:ll PRODUCT ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863, Recall # Z-1201-2007 REASON The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the...
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The pdf at the link provided is a reprint of an article entitled “Risk-Based Validation of Multilingual Medical Devices” co-authored by Alan Kusinitz, Managing Partner of SoftwareCPR, and Kai Simonsen of the Crimson Life Sciences division Transperfect Translations for the AAMI Biomedical Instrumentation and Technology journal and published in the Summer of 2007. Reprinted with...
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Company:Dade Behring, IncDate of Enforcement Report:8/29/2007 Class:ll PRODUCT EasyLink Informatics System, software version 3.0, Part Number 1000034941, Recall # Z-1174-2007 REASON Sample ID and Patient results could be associated with the wrong patient. RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE, by letter dated July 3, 2007. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company:GE Healthcare Date of Enforcement Report:8/21/2007 Class:ll PRODUCT a) GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE, Recall # Z-1132-2007; b) GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE, Recall # Z-1133-2007; c) GE Healthcare Systems ComboLab System. Made up...
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Company: Abbott LaboratoriesDate of Enforcement Report:8/22/2007 Class:ll PRODUCT a) CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for diagnostic use., and CELL DYN Control Assay Disk, List Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Recall # Z-1170-2007 b) Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers...
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Company:Northwest Medical Physics Equipment, IncDate of Enforcement Report:8/15/2007 Class:ll PRODUCT ISOLOC 4.2 Software Part Number NT-NW-425-520. Radiation treatment software, Recall # Z-1147-2007p> REASON When the ISOLOC (Version 4.2) profile distance unit is set to “centimeter” and the user clicked the “back” button in the digitizer window, the marker and target coordinates in the localization window...
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Company:Northwest Medical Physics Equipment, IncDate of Enforcement Report:8/15/2007 Class:ll PRODUCT Isoloc software Version 6.5, Part Number NT-NW-425-520. Software for image guided radiation therapy, Recall # Z-1145-2007p> REASON Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to “Anatomic Landmark” setting. RECALLING FIRM/MANUFACTURER Northwest Medical Physics Equipment, Inc., Everett,...
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Company:Northwest Medical Physics Equipment, IncDate of Enforcement Report:8/15/2007 Class:ll PRODUCT ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment, Recall # Z-1146-2007p> REASON This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update...
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Company:Medtronic Emergency Response Systems, IncDate of Enforcement Report:8/8/2007 Class:ll PRODUCT Biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers), Recall # Z-1148-2007 REASON Reduced Shock. The device may deliver 100 Joule (J) to a patient, which is less than...
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Company:Roche Molecular Systems, IncDate of Enforcement Report:8/8/2007 Class:ll PRODUCT a) Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests, Recall # Z-1106-2007; b) Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0, Catalog number 03576710190, Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122,...
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Company:Radiometer America IncDate of Enforcement Report:8/1/2007 Class:ll PRODUCT a) ABL 700 Series blood gas analyzers equipped with Software Version 3.833, Recall # Z-1094-2007; b) ABL 800 FLEX series blood gas analyzers containing software version 5.24, Recall # Z-1095-2007; REASON Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of...
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Company:Baxter Healthcare CorpDate of Enforcement Report:7/25/2007 Class:l PRODUCT Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore, product codes 2M8153, 2M8163, 2M9163, Recall # Z-1091-2007 REASON A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming...
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Company:Brainlab AGDate of Enforcement Report:7/11/2007 Class:ll PRODUCT BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; catalog/version number 40700-3A, Recall # Z-1010-2007 REASON Target Alignment Error. A mechanical component/software incompatibility caused by a specific combination of the BrainLAB...
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Company:bioMerieux, Inc Date of Enforcement Report:7/11/2007 Class:ll PRODUCT a) Vitatron C-Series dual chamber Rate Responsive Pacemakers (C60DR) includes the following models: C60A1 and C60A3 for US distribution and C50A1, ..A2, A3, C60A2 for international distribution (the single chamber is not involved). C-series software is VSF11/VSF12 Version 1.0. Recall # Z-0999-2007; b) Vitatron T-Series Dual Chamber...
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Company:Toshiba American Med Sys Inc Date of Enforcement Report:7/4/2007 Class:ll PRODUCT a) Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software, Recall # Z-0985-2007; b) Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software, Recall # Z-0986-2007 REASON When using the LV measurement function and making numerous measurements the value displayed...
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Company:Varian Medical Systems Inc. Date of Enforcement Report:7/4/2007 Class:ll PRODUCT LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1., Recall # Z-0978-2007 REASON A software anomaly in a medical device used for patient treatment could result in accidental or unintended radiation exposure. The tilt rotation compensation algorithm does not adequately...
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Company:Abbott Laboratories, Inc., Date of Enforcement Report:6/27/2007 Class:ll PRODUCT ) ARCHITECT i2000 Processing Module, for in vitro diagnostics; List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0950-2007; b) ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number: 3M74-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall...
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Company:General Electric Medical Systems Information Technology Date of Enforcement Report:6/20/2007 Class:ll PRODUCT GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (System hardware consists of a processing unit and a monitor), Patient Monitor, Recall # Z-0891-2007 REASON Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when...
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Company:Medtronic Emergency Response Systems, Date of Enforcement Report:6/13/2007 Class:ll PRODUCT LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics. Affected part numbers: 3202487-073 through -083; 3202487-087 through -090; 3202487-092; 3202487-093; 3202487-098; 3202488-036; 3202488-038...
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Company:General Electric Med Systems LLC, Date of Enforcement Report:6/6/2007 Class:ll PRODUCT a) GE Healthcare Innnova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System), Recall # Z-0869-2007; b) GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System), Recall # Z-0870-2007; c) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile...
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Company: Abbott Diabetes Care, Inc Date of Enforcement Report:5/30/2007 Class:ll PRODUCT Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Part Numbers: 99040-01, 99063-02.99514-01,97444-04, 97444-05,97445-05,97570-04, 98891-04,98929-05,98931-04, 98889-06, 98890-05, 98891-05, 98929-06,98931-05,99063-04, 99516-03, 80378-01,80379-01,80380-01, 80381-01, 80382-01,80383-01, 80392-01, 70519-01, 80392-02, Recall # Z-0709-2007 REASON If the time and date are...
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Recipient: Medico Labs, Inc. Product:drug products Date:4/16/2007 An inspection of your manufacturing facility was conducted from November 2 through November 16, 2006. During the inspection, our investigator documented deviations from the Current Good Manufacturing Practice (CGMP) Regulations, Title 21 Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211) for drug products...
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Company:GE Healthcare-Americas Signa 3.0T EXCITE Date of Enforcement Report:5/23/2007 Class:ll PRODUCT GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance system, Recall # Z-0815-2007 REASON To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included...
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Company:Misys Healthcare Systems Date of Enforcement Report:5/16/2007 Class:lll PRODUCT Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0115-07 REASON Blood Bank software, containing a glitch or defect, was distributed. CODE Version 6.1 and 6.2 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by e-mail dated August 16, 2006. Firm initiated recall is ongoing. VOLUME...
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Company:Misys Healthcare Systems Date of Enforcement Report:5/16/2007 Class:lll PRODUCT Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0561-07 REASON Blood Bank software, containing a glitch or defect, was distributed. CODE Version 6.1 and 6.2 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by e-mail dated November 10, 2006. Firm initiated recall is ongoing. VOLUME...
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Company:Misys Healthcare Systems Date of Enforcement Report:5/16/2007 Class:lll PRODUCT Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0549-07 REASON Blood Bank software, containing a glitch or defect, was distributed. CODE Version 6.1 and 6.2 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by e-mail dated November 8, 2006. Firm initiated recall is ongoing VOLUME...
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Company:Misys Healthcare Systems Date of Enforcement Report:5/16/2007 Class:lll PRODUCT Mysis Laboratory Blood Bank and Blood Donor Software, Recall # B-0114-07 REASON Blood Bank software, containing a glitch or defect, was distributed. CODE Version 6.1 and 6.2 RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by e-mail dated July 27, 2006. Firm initiated recall is ongoing. VOLUME...
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Company:Toshiba American Med Sys Inc., Date of Enforcement Report:5/9/2007 Class:ll PRODUCT Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Recall # Z-0771-2007 REASON Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature...
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Company:Instrumentation Laboratory Co., Lexington, MA, Date of Enforcement Report:5/9/2007 Class:ll PRODUCT GEM Premier 4000 Laboratory Analyzer, Recall # Z-0778-2007 REASON Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result. CODE Serial numbers prior to 07020343 with Software versions prior to V1.1.3 RECALLING FIRM/MANUFACTURER...
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Company:bioMerieux, Inc., Date of Enforcement Report:5/9/2007 Class:ll PRODUCT a) BacT/ALERT Classic System Software, Blood Culturing System, Recall # Z-0773-2007; b) BacT/ALERT 3D System Software, Blood Culturing System, Recall # Z-0774-2007; c) BacT/ALERT 3D Combo Systems Software, Blood Culturing System, Recall # Z-0775-2007; d) BacT/ALERT 3D 60 Systems Software, Blood Culturing System, Recall # Z-0776-2007 REASON...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Boston, MA)

Multiple participants from the same company: If you register 5 or more from the same company before March 15, 2025, receive a special discounted registration of $1999 per person.  These registrations may be transferred to another person at any time. Email training@softwarecpr.com to register and secure the TEAM discount.

 

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

 


 

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • Americas: 11-13 February 2025
  • EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
  • Southern Central Northeastern Pacific: 24-26 February 2025
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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