Company: Siemens Medical Solutions USA, Inc., Date of Enforcement Report 1/16/2008 Class:ll PRODUCT a) Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N: 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Recall # Z-0297-2008; b) Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version...Read More

Company: Toshiba American Med Sys Inc., Date of Enforcement Report 1/16/2008 Class:ll PRODUCT Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Recall # Z-0305-2008 REASON Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel...Read More

Company: SCC Soft Computer Date of Enforcement Report 1/16/2008 Class:ll PRODUCT Softbank II Software Version 23.1 with database Management System Interface. Report Unique Identifier: 1058332-04/07/2006-011-C, Recall # B-0504-08 REASON Software with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER SSCC Soft Computer, Clearwater, FL, by e-mail on May 9, 2005. Firm initiated recall is complete....Read More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089402.htmRead More

Company: Philips Medical Systems Date of Enforcement Report 1/2/2008 Class:ll PRODUCT a) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. (The product is a software application that is installed in Philips Medical System CT scanners.), Recall # Z-0366-2008; b) Philips Medical Systems, Cardiac...Read More

Company: Ellex, Inc., Date of Enforcement Report 1/2/2008 Class:ll PRODUCT Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Recall # Z-0148-2008 REASON Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations....Read More

Company:Beckman Coulter Inc Date of Enforcement Report 1/2/2008 Class:ll PRODUCT a) COULTER LH750 Analyzer, Part Number: 6605632, Hematology analyzer, Recall # Z-0312-2008; b) COULTER LH780 Analyzer, Part Number: 723585, Hematology analyzer, Recall # Z-0313-2008; c) COULTER LH 500 Series System, Part Number: 178833, Hematology analyzer, Recall # Z-0314-2008; d) COULTER GEN*S System, Part Number: 6605381,...Read More

Company: Medtronic Navigation, Inc Date of Enforcement Report:12/26/2007 Class:lll PRODUCT Ortho Assay Software (OAS) Version 2.0.1. There is no product code for the OAS. OAS software is pre-loaded on the OAS workstation. The workstation on which the software is loaded has two product codes: Product Code 936415 – April 4, 1999 to April 24, 2007...Read More

Company: Data Innovations, Inc., Date of Enforcement Report:12/26/2007 Class:ll PRODUCT Data Innovations Instrument Manager Software versions 7.04.0001 through 8.04.03.01, Recall # B-0195-08 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Data Innovations, Inc., South Burlington, VT, by e-mail on September 19, 2007 and by follow-up letter dated October 11, 2007. Firm initiated...Read More

Company: Accuray Inc, Date of Enforcement Report:12/19/2007 Class:ll PRODUCT Accuray, Multiplan Treatment Planning Software, Recall # Z-0364-2008 REASON Software problem – Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation. RECALLING FIRM/MANUFACTURER Accuray Inc, Sunnyvale, CA, by Urgent Advisory Notification on March...Read More

Company: Philips Medical Systems Date of Enforcement Report:12/195/2007 Class:ll PRODUCT Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Recall Z-0451-2008 REASON Alarm failure: If changes are made to the Care Group Editor configuration, Care Group alarm status,...Read More

Company:Abbott Laboratories, Inc Date of Enforcement Report:12/19/2007 Class:ll PRODUCT a) ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106- 01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10, Recall $ Z-0146-2008; b) ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20,...Read More

Company: GE Healthcare Advantage WorkstationsDate of Enforcement Report:12/19/2007 Class:ll PRODUCT GE Healthcare Advantage Workstations, Advantage Workstation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel...Read More

https://www.softwarecpr.com/Docs/Jmurray-AAMI-Webinar-December-4-2007-A.pdfRead More

Brian Fitzgerald Deputy Division Director, Division of Electrical and Software Engineering, FDA CDRH, Office of Science & Engineering Laboratories, provided a list of software analysis tools FDA’s laboratory uses in evaluating medical device code. This was in response to a question posed at a recent AAMI Webinar that John Murray of FDA and Alan Kusinitz...Read More

Company: Medtronic Navigation, Inc Date of Enforcement Report:12/5/2007 Class:ll PRODUCT Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, (software version 3.0), Recall # Z-0294-2008 REASON Reversed Instrument Position: a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180′ on the StealthStation image. (If...Read More

Company:Misys Healthcare Systems Date of Enforcement Report:12.5/2007 Class:ll PRODUCT Misys Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2, Recall # B-0317-08 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, by e-mail on August 24, 2007. Firm initiated recall is ongoing. VOLUME...Read More

Company:Siemens Medical Solutions USA, Inc., Date of Enforcement Report:12/5/2007 Class:ll PRODUCT a) Siemens ECAT ACCEL, Catalog No. 3545584, PET/CT Scanner, Recall # Z-0269-2008; b) Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Recall # Z-0270-2008; c) Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Recall # Z-0271-2008; d) Siemens ECAT EXACT HR 47, Catalog...Read More

Company:Toshiba America Medical Systems, Inc., Date of Enforcement Report:12/5/2007 Class:ll PRODUCT Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equipped with Digital Radiography System with Software version 3.4er000, Recall # Z-0293-2008 REASON System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.. RECALLING FIRM/MANUFACTURER Recalling Firm: Toshiba America Medical...Read More

In an AAMI Webinar John Murray of FDA indicated that it appears that software issues comprise 16 percent of medical device recalls and there is some thought to developing some special procedures for handling these. SoftwareCPR has found approximately 75 recalls related to software as of the end of November 2007 for the year which...Read More

Recipient:Cardinal Enterprises, Inc Product: drug products. Date: 12/1/2007 This inspection revealed significant deviations from Current Good Manufacturing Practice (cGMP) Regulations (Title 21, Code of Federal Regulations (21 “CFR), Parts 210 and 211). These deviations cause the drug products manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food,...Read More

Company: Philips Medical Systems t Date of Enforcement Report:11/28/2007 Class:ll PRODUCT Philips, Voxel Q workstations, utilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 and any Mx8000, Mx8001DT, or Brilliance 6, 10, 16, 16P, and Big Bore CT systems connected to the VoxelQ, Recall # Z-0180-2008 REASON...Read More

/docs/ORA-BIMOCPG7348-808-att_a.PDFRead More

Company: Toshiba American Med Sys IncDate of Enforcement Report:11/21/2007 Class:ll PRODUCT a) NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Recall $ Z-0253-2008; b) NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0, Recall...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report:11/14/2007 Class:ll PRODUCT The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application. All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is...Read More

Company:GE Healthcare Date of Enforcement Report:11/14/2007 Class:ll PRODUCT GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; Recall # Z-0113-2008 REASON When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is...Read More

Company: Medtronic Inc. Cardiac Rhythm Management Date of Enforcement Report:11/14/2007 Class:lll PRODUCT Medtronic Paceart System, 2006 Edition, The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices; Recall # Recall...Read More

CENELEC decides to include 62304 harmonization for the IVD directive based on a recommendation of TC 62. This is in addition to the MDD and AIMD.Read More

https://www.softwarecpr.com/docs/CBERbecsvalidationguidanceDraft1007.pdfRead More

/docs/FDAUserFeesFiscal2008.pdfRead More

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...Read More

Company: Beckman Coulter Incl, Date of Enforcement Report:10/24/2007 Class:ll PRODUCT FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Recall # Z-0002-2008 REASON Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter...Read More

Company: Medtronic Neurological, Date of Enforcement Report:10/17/2007 Class:ll PRODUCT Medtronic InterStim II INS Model 3058 with N’Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N’Vision with a Clinican Programmer Model 8840. Implantable Neurostimulator for Urinary Control. Catalog # 8870MM01 & 8870NNB01, Recall # Z-0037-2008 REASON A software issue may cause a lower than...Read More

/Docs/FDA-IOMerecordssection2007.pdfRead More

http://1.usa.gov/MLAXIURead More

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.Read More

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.Read More

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...Read More

http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html#2Read More

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...Read More

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,...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

http://www.fda.gov/cdrh/osel/guidance/321.pdfRead More

/docs/FDAOIVD-IVDMIAdraftguidance072507.pdfRead More

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...Read More