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Company: Roche Diagnostics CorpDate of Enforcement Report: 10/22/03 Class: II PRODUCT Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Recall # Z-0012-04. REASON Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted. CODE All units with current software...
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Company: Tri-State Analytical Laboratory LLCProduct: Analyzed drug products Date: 10/22/03 Inadequate Standard Operating Procedures that are not always available, lack appropriate details, or contain contradictory information. For example, the written procedure for method validation lacks detailed instructions and acceptance criteria for each test and conflicts with the protocol. Additionally, some software application and microbiology lab...
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Company: Olympus America Inc.Date of Enforcement Report: 10/22/03 Class: II PRODUCT Olympus ImageManager Software, Common name: Medical image storage device {NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking.) Recall # Z-0047-04. REASON Software malfunction; potential for simultaneous cross-linking of...
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Company: Medi-Stat Inc.Product: Pulse oximeter sensors Date: 10/17/03 The Device Master Record you submitted is inadequate. A Device Master Record is specific for each device and must include or refer to the location of the following information: a.) device specifications, including appropriate drawings, composition, formulation, component specifications and software specifications; b.) production process specifications including...
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Company: DPC CirrusDate of Enforcement Report: 10/15/03 Class: III PRODUCT Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software. Recall # Z-1138-03. REASON Version 2.6 software was released however, it will not properly handle adjustment slopes. CODE All units. RECALLING FIRM/MANUFACTURER DPC Cirrus, Flanders, NJ, by Recall Technical...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 10/8/03 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-1240-03. REASON Software Defect. CODE Verison 5.3 through 5.3.2. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on July 23, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 466. DISTRIBUTION Nationwide.
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Company: Nutra Med Inc.Product: Over-the-counter and prescription drug products Date: 10/2/03 Failure to maintain records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems. [211.68(a)]. For example, equipment qualification was not adequate for the following drug manufacturing equipment: Double Cone Blender (_____ kg.), Fitzpatrick Fitzmill Comminuting Machine, Coating Pans, Kent...
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Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT a) Gyroscan ACS-NT with software versions R6x, R7x, R8x. Recall # Z-1227-03; b) Gyroscan NT-Intera. Recall # Z-1228-03; c) Gyroscan Intera 1.0T & 1.5T. Recall # Z-1229-03. REASON Patient burns from cables near or in contact with the patient during use. CODE a) 6808,...
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Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT HeartStart XL Defibrillator Monitor. Model M4735A. Recall # Z-1226-03.M CODE Units with software versions A.02.00 or greater. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter on September 2, 2003. Firm initiated recall is ongoing. REASON Instructions for use include additional information on configuration...
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Company: Consolidated Machine Corp.Product: Steam sterilizers Date: 9/24/03 Our inspection confirmed that in 1994 your firm introduced the Mark V microprocessor that is marketed as an attachment to all of your approximately fourteen steam sterilizers. This microprocessor is software driven and controls the time and temperature of the sterilization cycles. This microprocessor addition constitutes a...
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Company: Con-Cise Lens Co.Product: Rigid gas permeable contact lenses Date: 9/19/03 Failure to perform and document validation of computer software that is used as part of production [21 CFR 820.70(i)]. Specifically, the software used to control the DAC DLL Series 3…has not been validated. We note that seven items on the Form FDA 483 issued...
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Company: Philips Medical Systems.Date of Enforcement Report: 9/17/03 Class: II PRODUCT Easy Access PACS System with software. Recall # Z-471-3. REASON Potential display of an incorrect body part description on patient images. CODE Software Release 5, 6.2, or 7.2. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell, WA, by letter on February 13, 2002. Firm initiated recall...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 9/17/03 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-1220-03. REASON Software Design Defect. Under certain conditions, results are removed. CODE Version 3.x. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ by facsimile on July 24, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 9/17/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1217-03. REASON Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported. CODE Version 5.2 through 5.3.2 using LabAccess Results. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on...
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/Docs/BloodBankingComputerValidationguidelines-ISBT-1202.pdf
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While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach. According to the Danish Competent Authorities the European Union (EU) approach is that equipment for blood banks including transfusion and information systems with clinical data about the donors, blood...
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Company: Harvard Clinical TechnologyDate of Enforcement Report: 9/17/03 Class: II PRODUCT Harvard 2, Dual Infusion Pump (P/N 2002-001). Recall # Z-1208-03. REASON Under specific sequence conditions, the unit may appear to be infusing, but is not. CODE Software versions V1.2R or earlier. RECALLING FIRM/MANUFACTURER Harvard Clinical Technology, South Natick, MA, by letter on August 11,...
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Company: Laborde Diagnostics at South CollegeProduct: Mammography facility Date: 9/12/03 The specific deficiency noted above appeared on the MQSA Post Inspection Report, which was given to your facility by the state inspector along with instructions on how to respond to this finding. Your facility responded to this same noncompliance issue in a letter dated September...
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Company: Beckman Coulter, Inc.Date of Enforcement Report: 9/10/03 Class: II PRODUCT Access Immunoassay System Technical Update 03.1, Part number 387851. Recall # Z-1148-03. CODE Software version 3.29. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA., by telephone between June 18, 2003 and July 3, 2003. Firm initiated recall is ongoing. REASON Defective software media distributed with...
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Company: ABX Diagnostics, Inc.Date of Enforcement Report: 9/10/03 Class: II PRODUCT ABX Diagnostices Pentra 60C+ Hematology Analyzer. Recall # Z-1149-03. REASON Instrument fails to obtain correct patient information/results due to malfunction of the equipment’s sample door. CODE Software versions of up to 1.7. RECALLING FIRM/MANUFACTURER ABX Diagnostics, Inc., Irvine, CA, by letter on June 5,...
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Company: Abbott Laboratories, IncDate of Enforcement Report: 9/10/03 Class: II PRODUCT Abbott Aeroset System list number 9D05-01. Recall # Z-1142-03. REASON ICT assays run using a manual dilution will not be calculated correctly by the software. CODE All units. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by letter dated December 29, 2000. Firm initiated recall...
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Company: Medicapharma.comProduct: “Roaccutane Isotretinoin 10 mg tablet” Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part. “Accutane must not be used by females who are pregnant…must...
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Company: Medicine-MexicoProduct: “Isotrex Isotretinoina Gel 0.05%” Date: 9/9/03 “Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no...
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Company: Edrugnet.comProduct:”Roaccutane Isotretinoin 10 mg capsules” Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part, “Accutane must not be used by females who are pregnant…must be...
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Company: Today’s BusinessProduct:”Isotrex Isotretinoina Gel 0.05%” Date: 9/9/03 “Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no...
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Company: Medsmex.comProduct: “Isotrex Isotretinoina Gel 0.05% Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part, “Accutane must not be used by females who are pregnant…must be...
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The pdf at the link provided is a reprint of an article entitled “Software Test Coverage” authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal and published in the Spring of 2003. AAMI-BIT-Software-Test-Coverage Article
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Company: Olympus America, IncDate of Enforcement Report: 8/27/03 Class: II PRODUCT Olympus Image Manager Software. Recall # Z-1126-03. REASON Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system. CODE Versions 6.0 through 6.4. RECALLING FIRM/MANUFACTURER Olympus America, Inc., Melville, NY, by letters, dated...
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Company: Siemens Medical Solutions USA, IncDate of Enforcement Report: 8/27/03 Class: II PRODUCT a) MR Systems. Recall # Z-1087-03; b) Leonardo Workstations with software version 2022A/B, 2003A. Recall # Z-1088-03; c) Leonardo Workstations with software versions prior to 2022A. Recall # Z-1089-03. REASON Software problem. This error may cause the loss of peripheral image information...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 8/27/03 Class: II PRODUCT Misys Laboratory System versions 5.3 up to 5.3.2 with Lab Access Results Workstation. Recall # Z-1093-03. REASON Software defect. When Quality Assurance failure warnings are missing from a patient’s report abnormal results could be used for diagnosis or treatment. CODE Versions 5.3 up to...
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Company: Invacare Corp. Product: Power wheelchairs and scooters Date: 8/26/03 With regard to the 80 amp fuse and …wire assembly, the May 15, 2003 and May 20, 2003 responses indicate that an 80 amp current through this assembly is only sustained for a short period of time. Invacare states that a continuous 80 amp current...
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Company: Boston Scientific Corp.Product: Investigational medical device Date: 8/22/03 For example, the …and the …do not describe whether the monitor should verify all case histories and related documentation or only select a representative sample during the visit. If a sample is to be selected, the procedures do not state the size and composition of this...
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An article in the August 22, 2003, Los Angeles Times by Charles Ornstein and Tracy Weber, Times Staff Writers, describes an incident where “two patients die after alarms fail”. Read article:  LATimesarticle822
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Company:Astro Instrumentation LLCProduct: Chemistry analyzers and renal dialysis filter reprocessing system Date: 8/21/03 Your August 4, 2003 response stated that you routinely use electronic copies of the manufacturing procedures and that a lack of a computer at this work station prompted the use of a paper copy. The response states that you have placed a...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 8/20/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1092-03. REASON Patient files become mixed up due to a software defect. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare System, Tucson, AZ, by fax on July 2, 2003. Firm initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 1....
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Company: Misys Healthcare SystemsDate of Enforcement Report: 8/20/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1090-03. REASON Software anomaly allows patient reports to contain incomplete data used for Anatomic Pathology Module. CODE Version 5.3 and up to 5.3.2 with Anatomic Pathology Module. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on June 16,...
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Company: Alcon Laboratories, IncDate of Enforcement Report: 8/20/03 Class: II PRODUCT “Alcon Ladarwave Custom Cornea Wavefront System” Aberrometer software Version 7.91. Recall # Z-1078-03. REASON Software error could, under specific circumstances, allow the patient’s centration images and data to be stored incorrectly. CODE Serial Numbers: LWN1002Z LWN1003Z LWN1010Z LWN1011Z LWN1013Z LWN1023Z LWN1025Z LWN1035Z LWN1040Z LWN1440Z...
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Company: Bioflex Inc..Product: Electrical stimulation devices Date: 8/18/03 Failure to establish procedures to ensure that equipment is routinely calibrated, checked and maintained. [21 CFR 820.72(a)] For example, the…meter used to test the electrodes on the BioShort electronic stimulation garments has not been calibrated and there is no calibration program for this meter. Failure to establish...
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Company: Medex, IncDate of Enforcement Report: 8/6/03 Class: II PRODUCT Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea, (the pumps with different languages have different...
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Company: Roche Diagnostics, CorpDate of Enforcement Report: 8/6/03 Class: II PRODUCT MagNA Pure LC Instrument, Catalog number 2236931. Recall # Z-1044-03. REASON A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols. CODE All systems using software version 3.0. RECALLING FIRM/MANUFACTURER Roche...
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Company: Abbott Laboratories HPD/ADDDate of Enforcement Report: 8/6/03 Class: II PRODUCT AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21 (French label), and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0). Recall # Z-1047-03. REASON AFP results obtained when using the 1:101 automated dilution protocol showed an...
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The AAMI Software Risk Management Technical Information Report working group has issued a draft for comment to those interested in providing early informal feedback. Contact one of the co-chairs for more information: Alan Kusinitz Managing Partner of SoftwareCPR at alan@softwarecpr.com or Paul Jones of FDA at pxj@fdadr.cdrh.gov.
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Company: Roche Diagnostics, CorpDate of Enforcement Report: 7/30/03 Class: II PRODUCT MagNA Pure LC Instrument; Catalog number 2236931. Recall # Z-1001-03. REASON Potential for false negative patient results with software version 3.0. CODE All units with software version 3.0. RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN, by letter dated May 27, 2003. Firm initiated recall...
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Company: Misys Healthcare SystemsDate of Enforcement Report: 7/30/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1007-03. REASON Software anomally. Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal disignations. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/30/03 Class: II PRODUCT Magic View 1000U, version VE40A. Digital Image Communication System. Recall # Z-1029-03. REASON Software issue. New examinations may not be saved properly and the examination may be lost. CODE Part number 7502003. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA, by...
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Company: Mercy Medical Center Product: Blood bank facility Date: 07/25/03 Failure to maintain an adequate number of trained and experienced personnel for the processing, compatibility testing, storage, and distribution of blood or blood components. For example, employee…who was responsible for completing validation of the …software, was also responsible for Quality Assurance, supervisory and administrative duties,...
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Company: Siemans Medical Solutions USA, IncDate of Enforcement Report: 7/23/03 Class: II PRODUCT Axiom Aristos X-Ray System. Recall # Z-0984-03. REASON Software malfunction. May indicate that the image is flipped when it is not. CODE Part numbers 5895003 and 7414803. Serial numbers 01001, 01170, 01219, 01221, and 01030. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc.,...
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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)

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