Recipient:Con-Med Corp.Product: Irrigation pumps, hand pieces and surgical drills Date: 6/29/05 Software flags were added to rechargeable batteries after complaints were received referencing the battery’s depletion during surgery. No verification or validation of this corrective action was conducted. FDA District: Florida District OfficeRead More

/docs/SCPRed/SoftwareCPR-Newsletter0605.pdfRead More

Company: Hitachi Medical Systems America Inc.Date of Enforcement Report: 6/22/05 Class: II PRODUCT a) Hitachi Altaire Magnetic Resonance Imaging Device. Recall # Z-0888-05; b) Hitachi AIRIS II Magnetic Resonance Imaging Device. Recall # Z-0889-05; REASON Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder. c) Hitachi...Read More

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Recipient: Millennium Dental Technologies IncProduct: Medical devices Date: 6/7/05 Our inspection found the following device QSR deficiencies Software used as part of the quality system has not been validated for its intended use according to an established protocol. Specifically, you are using a software system for your procedures that allows procedures to have inconsistent effective,...Read More

Recipient: Robert Hostoffer D.O.-Allergy and Immunology AssociatesProduct: Investigational biologics product Date: 6/6/05 You failed to collect the paper diary or electronic diary data as required by the protocol. The protocol stated that the paper diary was to be reviewed during the subject’s periodic visits with the clinical investigator (every 3-4 weeks) and that the electronic...Read More

Recipient: C & M Oxyfill LLC.Product: Compressed Oxygen USP Date: 5/26/05 Failure to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance [21 CFR 211.68(a)]. Specifically, your firm has not performed any equipment qualification on the “mobile” cryogenic pumping system which transfills your Compressed...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 5/25/05 Class: II PRODUCT Philips Medical HeartStart MRx Monitor/Defibrillator, Model: M3535A, M3536A. Recall # Z-0848-05. REASON The device may disarm and not deliver shock when performing a Synchronized Cardioversion. CODE Software Versions A.03.00 or lower and B.04.00 and lower. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter...Read More

Recipient: BioImageneProduct: PATHIAM software Date: 5/25/05 According to your website, PATHIAM is “a hardware-independent, Web-enabled software allowing pathologists to view and analyze immunohistochemically-stained (IHC-stained) slides from any computer via the Internet.” PATHIAM is a device as that term is defined in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S .C. 321(h))...Read More

The EU issued proposed new text for the Medical Device Directive (MDD). The document with highlighted revisions, additions, and deletions is at the link provided. The proposed changes include several additions to more explicity address software. These include adding: the word “software” into the definition of a medical device in section 2(a) Annex I 12.1b...Read More

The EU issued a proposal to modify the MDD. This proposal expresses several suggestions related to software. The full text is at the link provided. EU proposal for revision of MDDRead More

Company: Diasorin Inc.Date of Enforcement Report: 5/18/05 Class: III PRODUCT Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin Anafluor Indirect Fluorescent Antibody Test. Recall # Z-0807-05. REASON A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are...Read More

/docs/FDASoftwareSubmissionGuidance.pdfRead More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 5/11/05 Class: II PRODUCT Axiom Artis X-Ray System using software version VB11D or VB20B. Recall # Z-0796-05. CODE Model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350. RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated...Read More

/docs/FDASoftwareSubmissionGuidance.pdfRead More

Recipient: Electrologic of America Inc.Product: Electrical muscle stimulator stationary bicycles Date: 5/9/05 Failure to verify, validate and create a design history file when design changes were made to the StimMaster electrical muscle stimulation stationary bicycle [21 CFR 820.30(i) and (j)]. Engineering Change Notice, dated 11/1/02, states that four inches were removed from the front of...Read More

Recipient: Philips Medizin Systeme GmbhProduct: IntelliView patient bedside monitors Date: 5/6/05 CAPA investigation 4921 for complaints M2003-009925 and M2003-010130 received from the same hospital regarding a failure in the arrhythmia analysis software was not further investigated to determine whether similar defects in heart rate monitoring were reported by other facilities. Documentation shows the hazard/ risk...Read More

Company: Cerner CorporationDate of Enforcement Report: 5/4/05 Class: II PRODUCT HNA Classic 306 Patient Manager Blood Bank Software. Recall # B-0843-5. REASON Defects in the design of blood bank software could result in loss of patient antibody information. CODE Revision 159 and higher. RECALLING FIRM/MANUFACTURER Cerner Corporation, Kansas City, MO, by telephone calls beginning on...Read More

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Recipient: Pace Tech Inc.Product: Stationary and portable patient monitors Date: 4/29/05 Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures as required by 21 CFR 820 .75(a). Your firm fails to conduct...Read More

Recipient: Inoveon Corp.Product: Diabetic Retinopathy 3DT System Date: 4/27/05 Failure to establish and maintain adequate procedures for validating the device design to ensure that the device conforms to user needs and intended uses and include risk analysis, as required by 21 CFR 820.30(g) [FDA 483, Item 15]. For example, a formal risk analysis of the...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/27/05 Class: III PRODUCT Version 7 software for wash program on Bio Tek Automated Microplate Washer Model Elx50 which performs the washing steps for various programmed mictotiter plate assays. Recall # Z-0703-05. REASON When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/27/05 Class: III PRODUCT Version 12 software program written for the Bio- Tek ELx800 automated microtiter plate reader with use of PRO- Trac Tacrolimus ELISA kit. Recall # Z-0702-05. REASON The software program written for use in the automated microtiter plate reader (Bio- Tek ELx800) for use with the...Read More

Recipient: Digicare Biomedical Technology Inc.Product:Pulse oximeters and multiparameter patient monitors Date: 4/26/05 However, your firm lacked major steps for effective internal audits, including design control, software validation, corrective and preventive action (CAPA), and Electrostatic Discharge (ESD) reduction activities. Also, the individual conducting the audits lacks the necessary training and experience to conduct such audits and...Read More

Company: Medtronic Surgical Navigation Technologies, Inc.Date of Enforcement Report: 4/20/05 Class: II PRODUCT Stealth Station Cranial Application v.4.5. Catalog Numbers: 960-201 and 9730888. Recall # Z-0711-05. REASON The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient. The user has the option to create and make...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluorescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604. Recall # Z-0676-05....Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Recall # Z-0674-05. REASON The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) is faulty in...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT Data reduction program written specifically for Bio-Tek Elx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit. Recall # Z-0673-05. REASON The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) was found to be faulty. This program...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT DiaSorin programming software written for a specific automated microtiter plate instrument, Bio-Tek Elx800 reader for use with the ENA 6 Screen ELISA kit assay. Recall # Z-0672-05. REASON An error in the Bio-Tek Elx800 microplate reader programming specifications for the ENA screen Assay exists in...Read More

Company: Maquet, IncDate of Enforcement Report: 4/20/05 Class: II PRODUCT KION Anesthesia System. Recall # Z-0710-05. REASON Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality. CODE Serial Number: 2034; 3416; 3417; 3418; 3419; 3420; 3027; 0501; 3394;...Read More

Company: Diasorin, IncDate of Enforcement Report: 4/20/05 Class: III PRODUCT Data reduction program software written specifically for Bio-Tek Elx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). Recall # Z-0675-05. REASON The data reduction program written for a specific automated microtiter plate reader (Bio-Tek Elx800) was...Read More

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072331.pdfRead More

Company: Cincinnati Sub-Zero ProductsDate of Enforcement Report: 4/13/05 Class: II PRODUCT Micro-temp II heat therapy unit, model #747. Recall # Z-0671-05. REASON There is the potential that the power switch assembly can dislodge from the cabinet during use. CODE All units containing version 0.70 software. RECALLING FIRM/MANUFACTURER Cincinnati Sub-Zero Products, Cincinnati, OH, by letters dated...Read More

Recipient: Rosenthal Eye and Facial Plastic Surgery.Product: Investigational devices Date: 4/11/05 Our review of the inspection results also noted that you use an electronic medical record (EMR) system to maintain medical and other clinical data for your patients, including study subjects . You told Mr. Steyert that data obtained during study visits are entered directly...Read More

http://www.fda.gov/ohrms/dockets/dockets/04p0429/04p-0429-let0001-vol1.pdfRead More

/docs/FDA040105-kesslerRiskInitiative.pdfRead More

Recipient: General Electric Inc.Product: X-ray and fluoroscopic systems Date: 3/31/05 For example, your firm uses electronic database systems to document, track, and control corrective and preventive actions. The Correct Action/Preventive Action System procedure, _____, does not reference the use of these database systems, nor does it describe the steps necessary to close corrective and preventive...Read More

AAMI Standards Conference Software Session 2005 including 4 FDA presentations The following are all included in the pdf at the following link: AAMI Standards Conference Software Session 2005 Review of Software in Premarket Submissions (new guidance for CDRH and CBER) – David S. Buckles FDA CDRH ODE Cybersecurity for Networked Medical Device Containing (OTS) Off-the-Shelf Software...Read More

Company: Philips Medical Systems Sales and Service Region No. Americ.Date of Enforcement Report: 3/30/05 Class: II PRODUCT Xcelera R1.2. Cardiology image and information management solution software. Recall # Z-0640-05. REASON Loss of image data from image repository and archive requiring patients to undergo repeat imaging. CODE Xcelera Software version R1.2. RECALLING FIRM/MANUFACTURER Philips Medical Systems...Read More

Company: Heartsine Technologies, IncDate of Enforcement Report: 3/30/05 Class: I PRODUCT Heartsine Samaritan AED Defibrillators — Models: SAM 001, SAM 002,SAM 003. Recall # Z-0641-05. REASON The affected Automatic External Defibrillators (AED) announce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow...Read More

Recipient: Tosoh Bioscience Inc.Product: Immunoassay diagnostic packs and immunoassay systems Date: 3/22/05 Specifically, our inspections revealed that on or about March 27, 2003, your firm was notified by Tosoh Corporation, Tokyo, Japan that a new software revision, version 3.12, was being released to correct washing errors in the analyzer that resulted in discrepant troponin results....Read More

Recipient: Alternative Health & Herbs RemediesProduct: Squaw Vine, Parsley Herb, Mistletoe (European) and other tinctures Date: 3/17/05 Failure to exercise strict controls over labeling issued for use in drug product labeling operations [21 CFR 211.125(a)]. Specifically, your firm currently does not issue labels, review them for accuracy, or reconcile them; any extra labels from a...Read More

Recipient: William Gray M.D. – Swedish Medical CenterProduct: Investigational devices Date: 3/16/05 In response your written response, you claim that investigators will continue to work with management and staff to assure protocol adherence. Also, the department has installed new software that provides a check-list for study protocol required procedures. This change should assist you in...Read More

Recipient: ITO Co. Ltd.Product: US- 100 Portable Ultrasound Therapy Unit, SW-180 Shortwave Therapy Unit, TM-300 Traction Section and other physiotheraphy equipment Date: 3/7/05 Failure to submit a written report to FDA of a correction or removal initiated by the manufacturer to reduce a risk to health by the device, as required by 21 CFR 806.10....Read More

/docs/SCPRed/SoftwareCPR-Newsletter0205.pdfRead More

Company: Cardiac Science, Inc.Date of Enforcement Report: 2/16/05 Class: II PRODUCT a) Powerheart AED G3 Automated External Defibrillator Model 9300E. Recall # Z-0398-05; b) Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Recall # Z-0399-05. REASON AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this...Read More

/Docs/FDAImplantableIDguidance1541.pdfRead More

/docs/FDACybersecurityHealthcareOrganizationFAQ.pdfRead More

Company: Baxter HealthcareDate of Enforcement Report: 2/9/05 Class: II PRODUCT Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0392-05. REASON A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being...Read More