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

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

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

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

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

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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/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

Company: Baxter HealthcareDate of Enforcement Report: 2/9/05 Class: II PRODUCT Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0394-05. REASON Logix-CM software version 3.0.4 has not completed its official release process. CODE Software version 3.0.4. RECALLING FIRM/MANUFACTURER Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing. VOLUME OF...Read More

Company: Baxter Healthcare Renal DivisionDate of Enforcement Report: 2/9/05 Class: II PRODUCT HomeChoice PRO Automated Peritoneal Dialysis Systems. Recall # Z-0397-05. REASON A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products. CODE Units with software version 8.7 used with Physioneal...Read More

Recipient: The Byran Co. Inc.Product: Implantable surgical spine screws and rods Date: 2/3/05 Software validation activities for your automated computer system used as part of production have not been performed or documented for its intended use according to an established protocol, as required by 21 CFR 820.70(i). Specifically, the software used for setting the specifications...Read More

http://www.fda.gov/cdrh/osel/programareas/software.htmlRead More

Recipient: John Marcum M.D. – Childrens Hospital Los AngelesProduct: Investigational device Date: 1/27/05 Records relating to correspondence with the IRB and sponsor, including required reports, are not all complete. For instance, there is no correspondence demonstrating that the sponsor and IRB were notified of all adverse events and serious adverse events, including the nine infections...Read More

/Docs/FDAmeetingsbestprac04.pptRead More

Recipient: GE Healthcare TechnologiesProduct: Diagnostic x-ray system Date: 1/19/05 Failure to respond constitutes a violation of the Act, Sections 538(a)(2) and 538(a)(4) of Sub-chapter C – Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968). Failure to promptly correct this violation can result in regulatory action being initiated by...Read More

Company: Baxter Healthcare Corp.Date of Enforcement Report: 1/12/05 Class: II PRODUCT a) Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R; Made in Singapore; monochrome display screen. Recall # Z-0342-05; b) Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153R; Made in Singapore; monochrome display screen. Recall # Z-0343-05; c)...Read More

Company: Dade Behring, IncDate of Enforcement Report: 1/12/05 Class: II PRODUCT StreamLab Analytical Workcell. General Purpose Laboratory Device. Recall # Z-0373-05. REASON Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems. CODE Software version 3.5. RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE, by letters dated November 12,...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 1/12/05 Class: II PRODUCT Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use), M3536A (EMS Use). Recall # Z-0341-05. REASON In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy. CODE...Read More

Company: Cincinnati Sub-Zero ProductsProduct: Class II hypo/hyperthermic machines Date: 1/10/05 Your Customer Communication Procedure states the “technical service manager or alternate shall document the analysis and conclusions of inquiry.” The procedure also states that “if no analysis is required, the technical service manager or alternate shall document the reason” and it should be in the...Read More

/docs/510kAssistedReproductionLaserSystems-122804.pdfRead More

Company: Toshiba American Med Sys IncDate of Enforcement Report: 12/22/04 Class: II PRODUCT Magnetic Resonance Imaging Systems, under the following names: Visart Excelart P2 Excelart P3 Excelart SPIN. Recall # Z-0273-05. REASON Software defect causes patient identification number to be truncated. CODE No specific codes were listed. RECALLING FIRM/MANUFACTURER Toshiba American Med Sys Inc, Tustin,...Read More

Company:Toshiba American Med Sys IncDate of Enforcement Report: 12/22/04 Class: II PRODUCT Magnetic Resonance Imaging Systems under the following names: Visart, Excelart, Excelart P2, Excelart P3, Excelart SPIN, Excelart VANTAGE. Recall # Z-0270-05. REASON Software defect causes images to be rotated 180 degrees. CODE All serial numbers. RECALLING FIRM/MANUFACTURER Toshiba American Med Sys Inc., Tustin,...Read More

Company: Roche Diagnostics CorpDate of Enforcement Report: 12/22/04 Class: II PRODUCT MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-0297-05. REASON Test results may be adversely affected by software shutting down the cooling blocks in systems with software versions 3.09. CODE All systems using software version 3.09. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp.,...Read More

Company:Cyberonics Inc.Product: Vagus Nerve Stimulator Date: 12/22/04 During an inspection of your firm’s manufacturing operations located in Houston, Texas, on July 12 through September 15, 2004, United States Food and Drug Administration (FDA) Investigator, Ellen J. Tave, determined that your firm manufactures the Vagus Nerve Stimulator (VNS), an implanted generator that is indicated for use...Read More

Company: Coherent, InccDate of Enforcement Report: 12/22/04 Class: II PRODUCT Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. Recall # Z-0360-05. REASON Software problem that may cause unintended emission of laser radiation. CODE All serial numbers are affected by this recall action. Serial numbers range from 1003 to 1092....Read More

Company: Precision Piece Parts IncProduct:. Ilio-sacral bone screws Date: 12/15/2004 You failed to validate the original and subsequent changes to computer software used to control automated production and quality system operations, as required by 21 CFR 820.70(i). [See, for example, FDA483 observations 18 and 19.]. FDA District: Detroit District OfficeRead More

Company: Beckman Coulter, IncDate of Enforcement Report: 12/15/04 Class: II PRODUCT Access Immunoassay Systems, Discrete photometric chemistry analyzer. Recall # Z-0265-05. REASON A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 12/15/04 Class: III PRODUCT CXP software for Cytomics FC500 Cytometer. Recall # Z-0266-05. REASON Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect. CODE Versions 1.0, 1.1, and 2.0. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter of...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 12/15/04 Class: II PRODUCT DL2000 Data Manager Software, Version 6.4.108. Recall # Z-0267-05. REASON Possibility of reporting an incorrect result occurs due to a software anomally. CODE Version 6.4.108. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on November 5, 2004. Firm initiated recall is ongoing. VOLUME...Read More

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Company: Sooil Development Co. Ltd.Product:Insulin infusion pump Date: 11/24/04 Failure to document the results of the design validation in the design history file, as required by 21 CFR 820.30(g). For example, the documentation of the bolus and basal infusion testing involving the dispensing software was incomplete. Additionally, as part of your software validation, the report...Read More

Company: Ortek AGProduct: Shoulder, hip and knee prostheses Date: 11/19/04 Failure to validate computer software for its intended use for computers or automated data processing systems used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, the software used to control the automated _____ used to produce medical...Read More

Company: Nuclear Cardio Systems Inc.Product: Emission computed tomography systems Date: 11/17/04 In addition, our investigators reviewed _____ of your firm’s service reports. _____ of these reports appeared to meet the definition of a complaint [21 CFR 820.3(b)]; however, none of these were considered by you to be complaints and were not included in your complaint...Read More

Company: Med-El Elektro-Medizinische Gerate GmbHProduct: Combi C40+ and Pulsar cochlear implant systems Date: 11/16/04 Failure to establish and maintain procedures for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems....Read More

Company: Clarity Inc.Product: Otologic implants Date: 11/12/04 Failure to document software validation activities for computers or automated data processing systems used as part of production, as required by 21 CFR 820.70(i). Specifically, there is no documentation indicating the automated _____ lathes and mills used to manufacture device implants, have been validated. FDA District: New Orleans...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 11/10/04 Class: II PRODUCT Pagewriter Touch Cardiograph Software. Recall # Z-0063-05. REASON Software can generate printed ECG’s that associate incorrect patient data with the waveform. CODE Software Versions A.01.01 or A.01.02. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter on September 13, 2004. Firm initiated recall is...Read More

Company: Medical Industries America, Inc.Date of Enforcement Report: 11/10/04 Class: II PRODUCT Aeroneb Go Micropump Nebulizer Featuring OnQ electronic micropump, RX, Manufactured by Medical Industries America Inc., Adel, IA. The product is sold individually or in master packs of 8 under the following model numbers (all using the same box label): Model 7000 – Consisting...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 11/3/04 Class: II PRODUCT a) AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974. Recall # Z-0032-05. b) AXIOM Sensis Programmable diagnostic comp uter, Model number 66 34 633. Recall # Z-0033-05; c) AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641. Recall #...Read More