Company: Grand RapidsDate: 10/1/01 Product: Thumper cardiopulmonary resuscitator Your response to FDA-483 point #6 regarding 21 CFR Part 11 – Electronic Records is not adequate as explained in more detail below. 21 CFR Part 11 During the FDA inspection it was discovered that electronic records are used to establish the firm’s Complaint Files, 21 CFR...Read More

Recipient:Christ Hospital Product: blood bank Date: 9/27/2001 During an inspection of your unlicensed blood bank, conducted on July 26, 30 and August 1, 2001, our investigator documented violations of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act and Title 21, Code of Federal Regulations 211 and 600-680, as follows: Failure to conduct validation...Read More

Recipient:Dentsply International, Inc Product: dental handpieces and dental accessories Date: 9/26/2001 The inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System regulation...Read More

WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking. FDA has released it as a draft validation Guidance on Part 11 Electronic Records; Electronic Signatures. These guidance documents were developed by FDA’s Part 11 Compliance Committee. This is a draft, and industry comments will be important in shaping the final guidances. Submit...Read More

http://www.fda.gov/cder/guidance/4286fnl.pdfRead More

http://www.fda.gov/cder/regulatory/ersr/FDARegional/ectd.htmRead More

Company: SIEMENS MEDICAL SYSTEMS, INCDate of Enforcement Report: 9/19/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1106-1 – Z-1108-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Codes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 through...Read More

Company: B. Braun Medical Inc.Date: 9/17/01 Product: Disposable IV sets Failure to validate computer software used to (1) control the Eto sterilization process, for example, _____ cycles, and (2) control the _____ _____) employed in the manufacture of disposable IV sets, to ensure the software will perform for its intended use. 21 CFR 820.70(i). FDA...Read More

Company: Cleveland Medical Devices Inc.Date: 9/17/01 Product: Wireless medical telemetry monitoring systems No documented corrective and preventative action for software bugs found during retrospective validation. Validation testing revealed several responses that were unexpected and may potentially adversely effect the performance of the Model 15 The above stated inspection revealed that your devices are adulterated within...Read More

Company: SANGUIN INTL., INCDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1048-1 Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3 The software Medusa 2000 is an interface link to the Ortho Summit Processor (OSP) which is a mass processing device for microplate based assays [tests for viral markers by ELISA]....Read More

Company: Dade Behring Marburg GMBH MarburgDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software CODES: Model OVIO03, Version 2.2 REASON: Leak of piston pump valve introduces air bubbles. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, Inc., Newark, DE, by letter. FIRM INITIATED...Read More

Company: Applicare Medical ImagingDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0857-1/Z-0858-1 RadWorks Software Version 5.1 with Software Patch 5 or 7, and RadWorks WebViewer Software Verion 5.1 running on RadWorks 5.1 Software Patch 5 or 7; picture archival and communications system; Applicare Medical Imaging B.V., Zeist, The Netherlands Codes: RadWorks...Read More

Compnay: Siemens Medical Systems, IncDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0851-1 ICON Profile Processing Software used on the ICON P workstations designed for use with E.CAM Gamma Camera Systems to conduct cardiac Tomo and SPECT applications; 60195-5203. Codes: All E.CAM gamma cameras with the Profile option with ICON-P workstations...Read More

Company: GE Medical Systems, Information TechnologiesDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1078-1 Clinical Information Center Software. The brand name was Marquette when the product was initially distributed. CODES: All devices with V.2 and later revisions of the software. REASON: Device can improperly restart resulting in no alarms or information...Read More

Company: WELCH ALLYN PROTOCOL, INCDate of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1049-1 Acuity Central Monitoring Stations with software versions 4.03.00, 4.03.01,4.03.02, 4.03.03, 4.03.04, and 4.03.05 when connected to VHF/UHF telemetry units CODES: software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05 REASON: Incorrect Visual Display MANUFACTURER/RECALLING FIRM: WELCH ALLYN PROTOCOL,...Read More

Company: SIEMENS MEDICAL SYSTEMS, INC.Date of Enforcement Report: 9/12/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-1105-1/Z-1107-1 Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine proceduresCodes: a) Model 4380213 – E.CAM Gantry Single Head, serial numbers 0001 thru 2016 b) Model...Read More

Company: Total Medical Information Management Systems Inc.Date: 9/7/01 Product: Picture archiving and communications systems software During an inspection of your establishment located in Longwood, Florida on August 6-7, 2001, FDA Investigator Ronald T. Weber determined that your establishment is a manufacturer and distributor of picture archiving and communication systems software, which is a medical device...Read More

/docs/IEEE-NIH_CBMS_Safety_Model-13.pdfRead More

Company: Medica Corp.Date of Enforcement Report: 9/5/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0951-1 EasyBlood Gas Analyzer. REASON: PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg. CODES: EasyBlood Gas Analyzers with Software version below M4.20. MANUFACTURER/RECALLING FIRM: Medica Corp., Bedford, MA. RECALLED BY: Manufacturer, by fax on 8/15/00....Read More

Company: AGILENT TECHNOLGIES Date of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0948-01/Z-0949-01 Agilent Technologies (formerly Hewlett Packard Co.) (A)Anesthesia Monitoring Systems, M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with Release C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242...Read More

Company: Dade Behring Marburg GMBH MarburgDate of Enforcement Report: 9/5/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software version 2.2. REASON: Leak of piston pump valve introduces air bubbles. CODES: Model OVIO03 Version 2.2 MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, INC., Newark, DE., by letter...Read More

Company: DADE BEHRING, INCDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software, 5.1 REASON: Incorrect low results for a number of patient samples. CODE: Version 5.1 MANUFACTURER: DADE BEHRING, INC., NEWARK, DE RECALLED BY: Manufacturer, by letter 4/9/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION:...Read More

Company: Baxter Healthcare CorporationDate of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: B-1332-1, Amicus Separator Apheresis Instrument with software version 2.50 REASON: Blood collection device may return an inappropriate volume of plasma to a donor during an apheresis procedure. MANUFACTURER: Baxter Healthcare Corporation, Largo, FL RECALLED BY: Baxter Healthcare Corp., Round Lake,...Read More

Company: Siemens Medical Systems, Inc.Date of Enforcement Report: 9/5/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0769-1 – Z-0771-1 E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 CODES: a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and...Read More

Company: Lee Memorial Health System Date: 8/27/2001 Product: unlicensed blood banks The inspection revealed failure of your blood bank to adequately determine the suitability of persons to serve as whole blood donors. One donor (unit [redacted]) tested repeatedly reactive for HIV 1-2 in screening tests-performed on March 21, 2001 and was never placed in deferral....Read More

Company: Lee Memorial Health SystemDate: 8/27/01 Product: Blood bank The inspection revealed failure of your blood bank to adequately determine the suitability of persons to serve as whole blood donors. One donor (unit _____) tested repeatedly reactive for HIV 1-2 in screening tests performed on March 21, 2001 and was never placed in deferral. Donor...Read More

DATE RECALL INITIATED< br> August 24, 2001 PRODUCT / LOT NUMBER / EXPIRATION DATE: FlexiLab Blood Bank and Blood Donor Software, Software versions 5.2, 5.23, and 5.3 MANUFACTURER: Sunquest Information Systems, Inc. Tucson, AZ REASON: A software defect has the potential to result in blood components/derivates reaching inventory “Available Inventory Status” without a product testing...Read More

Company: SONOSITE, INCDate of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-868-1, Sonosite 180 – portable, software controlled ultrasound system intended for use with a variety of transducers to perform a variety of scans and measurements/calculations for the abdomen, pediatric scans, general cardiac, GYN/infertility, obstetrics. Code: Sonosite units with the following software...Read More

Company: SUNQUEST INFORMATION SYSTEMS, INCDate of Enforcement Report: 8/22/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0733-1, FlexiLab Laboratory Information System Version 5.2, 5.23, and 5.3 interfaced with Anatomic Pathology Lab Access Transcription Workstation. REASON: Software glitch MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., TUCSON, AZ RECALLED BY: A temporary procedural workaround was communicated to all...Read More

Company: ALARIS MEDICAL SYSTEMS, INCDate of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-748-1, Model PC-1 A one channel, general purpose, infusion pump, 220V CE Marked, International only (Software version 8.12 and 8.13) REASON: Motor stall MANUFACTURER/RECALLING FIRM: ALARIS MEDICAL SYSTEMS, INC., San Diego, CA RECALLED BY: International mailings are being coordinated...Read More

Company: DADE BEHRING MARBURGDate of Enforcement Repor: 8/22/01t Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0906-1, Behring Coagulation System (BCS) software version 2.2 REASON: Leak of piston pump valve introduces air bubbles MANUFACTURER: DADE BEHRING MARBURG, Germany RECALLED BY: DADE BEHRING, INC., GLASGOW, DE, by letter to the three accounts informing them of the problem...Read More

Company: SUNQUEST INFORMATION SYSTEMS, INCDate of Enforcement Report Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0735-1, FlexiLab Laboratory Information System, Version 5.23 REASON: Software anomaly MANUFACTURER/RECALLING FIRM: SUNQUEST INFORMATION SYSTEMS, INC., Tucson AZ RECALLED BY: A temporary procedural workaround was communicated to all affected customers in Product Safety Notice PSN-01-L18, June 8, 2001. FIRM INITIATED...Read More

Company: DADE BEHRING, INC.Date of Enforcement Report: 8/22/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software version 5.1 REASON: Incorrect low results for a number of patient samples MANUFACTURER/RECALLING FIRM: DADE BEHRING, INC., Newark, DE RECALLED BY: Manufacturer, by letter on 4/9/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION:...Read More

Company: Southeastern Home Oxygen Service Inc.Date: 8/7/01 Product: Medical Oxygen You failed to assure the adequacy of your firm’s current computer distribution tracking system. Review of 2 lots selected at random for comparison of production records with computerized tracking information revealed inconsistencies in the number of oxygen cylinders filled with those distributed. FDA District: Atlanta...Read More

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Company: American Blood Resources AssociationDate: 7/31/01 Product: Blood Bank Deferral Software During an inspection of your facility located in Annapolis, Maryland, on June 18 through 22, 2001, Food and Drug Administration (FDA) investigators determined that you manufacture and distribute, Blood Bank Deferral Software. This software is a device within the meaning of section 201(h) of...Read More

/docs/FDAProcessValPresentation051001-weber[1].pptRead More

Company: Kaken Pharmaceutical Co Ltd.Date: 7/27/01 Product: Drug Products Written procedures for production, process control, and laboratory operations were not always followed to assure that APIs have the appropriate quality and purity. The inspection reported numerous instances regarding the following operations which present a general practice of not following written procedures: -Stability testing -Storage of...Read More

Below is the classifcation rule. Note that this has been used for automated sample preparation systems of some types as well.TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 862_CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES–Table of Contents Subpart C_Clinical Laboratory Instruments Sec. 862.2050 General purpose laboratory equipment labeled...Read More

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Detail.CFM?STANDARD__IDENTIFICATION_NO=5188Read More

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

Date Recall Initiated:July 20, 2001 Product: Solar 9500 Physiological ECG Monitor Use: To monitor patient vital signs including blood pressure, pulse, temperature, cardiac output, respiration, and anesthetic gas concentrations during surgery. This product is intended for use under the direct supervision of a licensed health care practitioner. Reason for Recall: Incorrect computer chips were installed...Read More

Company: Toshiba America Medical Systems, Inc.Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0690-1, Impax Technology Inc. DDS Intended use is as Diagnostic Image Display Software Model/catalog number: DS3000, CS5000, XA3000 REASON: Wrong image presents to radiologist upon database query. MANUFACTURER/RECALLING FIRM: Toshiba America Medical Systems, Inc., Tustin, CA RECALL BY:...Read More

Company: SeQual Technologies Inc.Date: 7/18/01 Product: Oxygen Failure to ensure that a process whose results cannot be fully verified by subsequent inspection and testing, has been validated and approved according to established procedures [21 CFR 820.75(a)]. Specifically, your firm has no documented evidence that provides a high degree of assurance that the manufacturing specifications and...Read More

Company:Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE Z-0691-1 through Z-0693-1 Software used on the Computerized Tomography Fluoroscopy CT Fluroscopy option, model numbers TSXF-003A; TSXF-003B; TSXF-003C for Aquilion (Model No. TSX-101A) and Asteion (Model No. TSX-021A) Computed Tomography Scanners REASON: X-ray generation without operator command using unusual program sequence. MANUFACTURER/RECALLING FIRM:...Read More

/Docs/Part11forbiomedfocus07-01CNelsonPres.PDFRead More

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Company: Paul E. Garland M.D.Date: 7/11/01 Product: Excimer Laser Medical devices used by doctors in their course of their practice to treat patients are “marketed” and “held for sale” within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). An excimer laser is a class III device under section 513(f) of the...Read More

RECALL NUMBER, PRODUCT AND CODE:Company: Community Blood Center of Greater Kansas City Date of Enforcement Report: 7/11/01 Class: II B-1457-1, Red Blood Cells Units L04250, L02615, M84346, T52350, T033222,T031302, T028101, T025140, T012049, T007397 B-1458-1, Platelets, Pheresis, Units T038725, T035305, T034495 B-1459-1, Platelets Units T031302, T012049, T007397 B-1460-1, Fresh Frozen Plasma Units L04250 (divided into 4...Read More

Date of Enforcement Report: 7/11/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0629-1, Multi-Therapy Ambulatory Infusion Pumps sold under the following labels a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40 (English), 606000-40L (loaner pump) and 606000-40I (International) b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code 2M9832 REASON: Potential overinfusion in the Auto-Ramp mode...Read More