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Company:Serv-A-Pure Co.Product: Water purification systems for hemodialysis Date: 10/10/2002 Design Control and Design Inputs and Outputs. Your response to FDA-483 observation # 4 addresses the specific observation that the records were not signed and dated. We are concerned that the records referred to in this observation are maintained on a computer system, and your response...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Misys laboratory version 5.3 with custom Result Interface 11. Recall # Z-1405-2. REASON Software anomaly causing mixing of patient data. CODE Version 5.3 with custom Result Interface 11. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax on June 13, 2002. Firm...
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Company: Spacelabs Medical, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Recall # Z-1395-2/Z-1401-2. a) Telemetry Digital Processors Models 90342, 90344, 90346, 90348. Recall # Z-1395-2/Z-1398-2; b) Integrated Multiparameter Module Model 90470. Recall # Z-1399-2; c) Telemetry Receiver Module Model 90478. Recall # Z-1400-2; d) Ultarview Command Module Model 90496. Recall # Z-1401-2. REASON ECG...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Cytomics RXP software. Recall # Z-1387-2. REASON When analyzing multiple listmode files using a multi-file analysis protocol, incorrect percentage results may occur if “% in Regions” is selected. CODE Version 1.0. RECALLING FIRM/MANUFACTURER Beckman Coulter Inc., Brea, CA, by letters dated May 15,...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/9/02 Class: II PRODUCT Misys Laboratory. Recall # Z-0002-3. REASON Software anomaly. Quality assurance flags were not appearing as they should on cumulative reports. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002. Firm initiated recall is...
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Company: Abbott Laboratories, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Aeroset Software Version 1.01ER000. Recall # Z-1352-2. REASON Sample results may be skewed by failure to properly ‘blank’ the sample. CODE Catalog number 2-94815-01, The AEROSET Software is not controlled by lot or control numbers. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by telephone...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1377-2. REASON Software anomaly. Footnotes are incomplete and do not print on reports. CODE Version 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax on August 16, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company: Misys Healthcare Systems, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1378-2. REASON Software anomaly. When original results were modified or deleted in function MEH, original/unmodified results were saved. CODE Versions 5.2, 5.23, 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002.Firm initiated recall is...
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Company: Medical Data Electronics, IncDate of Enforcement Report: 10/02/02 Class: II PRODUCT Defibrillator/ Pacer Medical Research Laboratories external adult defibrillator paddle set- used with Medical Data Electronics Escort defibrillator pacer models 20201 and 20202. Recall # Z-1360-2. REASON Intermittent operation of the paddles. CODE Serial Numbers 10392 thru 10540. RECALLING FIRM/MANUFACTURER Recalling Firm: Medical Data...
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Company: Med-Mart Pulmonary ServicesProduct: Inhalation solutions Date: 9/30/02 Failure to perform routine calibration and to assure proper performance of all automatic, mechanical, and electronic equipment used in the manufacture, processing, packing, and holding of a drug product [21 CFR 211.68]. For example, your filtration unit, _____ small batch filler unit, industrial scale, _____ Pump, and...
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Company: Becton Dickinson Microbiology SystemsDate of Enforcement Report: 9/25/02 Class: II PRODUCT Becton Dickinson’s EpiCenter Data Management System software. Recall # Z-1338-2. REASON IVD software defect may cause incorrect patient results to be reported. CODE EpiCenter Software, version 3.20B, Catalog #441007. RECALLING FIRM/MANUFACTURER Becton Dickinson Microbiology Systems, Sparks, MD, by letter on August 1, 2002....
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Recipient: Ronald G. Crystal M.D.Product: Investigational biologic products Date: 9/23/02 Subject _____ was enrolled in the study without Computerized Tomography (CT) documentation of the number of _____ present at the time of enrollment. Section 3.2 of the protocol requires that the subject have two or more _____ detected by CT scan. Issuer: Center for Biologics...
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Company: Mysis Healthcare Systems, IncDate of Enforcement Report: 9/18/02 Class: II PRODUCT Misys Commercial Laboratory. Recall # Z-1318-2. REASON Software anomaly. If the deformatter begins to process data prior to all patient result records or orders being extracted from the flat files, the remaining results or orders will not be extracted. This can result in...
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Company: Mysis Healthcare Systems, Inc.Date of Enforcement Report: 9/18/02 Class: II PRODUCT Mysis Commercial Laboratory. Recall # Z-1285-2. REASON Software anomaly: a result for an accesion number came across the interface as negative but should have been Do Not Result (DNR). CODE Versions 3.2.0; 3.2.2; 3.2.3, 3.3.0, 3.3.1a, 3.3.1, 3.4.0, 3.4.1b, and 3.4.1a. RECALLING FIRM/MANUFACTURER...
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Company: Misys Healthcare Systems IncDate or Enforcement Report: 9/18/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1281-2. REASON Software anomaly regarding cell counts. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems Inc., Tuscon, AZ, by fax on April 23, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 469. DISTRIBUTION...
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Company: University of Massachusetts Memorial Medical Center.Product: Blood products Date: 9/12/02 In no more than fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps you have taken to correct these violations and to prevent them from recurring. Your response should also indicate the status of the...
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/docs/FDAPart11DraftArchivingGuidance00d-1539-nad0001.pdf
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Company: Unit Dose Packaging Inc.Product: Drug products Date: 8/29/02 Failure to establish a written procedure to calibrate, inspect, and check automated, mechanical, or electronic equipment used to manufacture drug products to assure proper performance. [21 CFR 211.68 (a)]. Specifically, there is no data to demonstrate that production equipment (two mixers, one filler, a water system)...
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Company: Roch DiagnosticsProduct: Accu Check Inform Blood Glucose System Class II Date of Enforcement Report: 8/28/2002 All units that have ever displayed a temperature icon in conjunction with patient use. Reason: May give erroneous results if the temperature icon has ever been displayed with use. Manufacturer: Roch Diagnostics, Mannheim, Germany. Recalled by: Roche Diagnostics Corporation,...
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Company: Diasorin IncDate of Enforcement Report: 8/28/02 Class: II PRODUCT Medusa software, DiaSorin Part 15794, for an OMNI (automated microtiter plate) Instrument used for the ETI-HA-IGMK Plus Enzyme Immunoasay for the Detection of IgM Antibody to Hepatitis A Virus in Human Serum or Plasma. Recall # Z-1265-2. REASON As a result of a software error,...
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Company: Bayer CorporationDate of Enforcement Report: 8/21/02 Class: III PRODUCT Brand Name: ADVIA Centaur(R) Analyzer. Recall # Z-1233-2. REASON Software programming error. CODE All serial numbers distributed with Model/Part Number 572561, along with all existing software versions from 2.1 to 2.5. RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corporation, Business Group Diagnostics, Tarrytown, NY, by letter on...
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Company: Dade Behring, IncDate of Enforcement Report: 8/21/02 Class: II PRODUCT Dimension(R) Xpand software revision 6.0.1 and 6.1 (Clinical Chemistry Analyzer). Recall # Z-1226-2. REASON The sample probe does not accurately track the fluid level. CODE Xpand software revision 6.0.1 and 6.1. RECALLING FIRM/MANUFACTURER Recalling Firm: Dade Behring, Inc., Newark, DE, by telephone on May...
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Company: University Hospitals of ClevelandProduct: Blood products Date: 8/19/02 With respect to your response to FDA-483 item #2, you stated that you will institute a computer change. We expect that changes to the computer system should be validated. Please provide documentation of the validation for this new change. Additionally, please explain what actions and/or retraining...
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Company: Baxter Healthcare CorpDate of Enforcement Report: 8/14/02 Class: I PRODUCT Logix-CM Compounder Software. Recall # Z-1203-2. REASON Software allows ingredient concentration errors during compounding. CODE Catalog #2M8400, Logix-CM software version 1.0.2. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL, by telephone on June 18, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...
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On August 14, 2002, the HIPAA final privacy rule 45 CFR Parts 160 and 164 were modified to respond to comments and to reduce the administrative burden of the rule.  A copy of the new rule can be view here:  HIPAA Modified Final Privacy Rule 2002-08. Medical Device manufacturers that produce devices that will maintain patient...
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Company: Siemens Medical Solutions USADate of Enforcemet Report: 8/14/02 Class: I PRODUCT e.soft software version 2.0 used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or e.soft A/P nuclear medicine workstations. Recall # Z-1189-2. REASON Incorrect image time stored for static images resulting in incorrect results. CODE e.soft software version 2.0 installed...
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http://www.fda.gov/ohrms/dockets/dockets/00d1538/00d1538.htm
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Company: Philips Medical SystemsDate of Enforcement Report: 8/7/02 Class: II PRODUCT 1.5T MR Systems with software version R7.1.2 and higher: Magnetic Resonance Systems are indicated for use as diagnostic devices that produce transverse, sagital, coronal and oblique cross-sectional images, spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that display the internal structure...
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Company: Philips Medical Systems Date of Enforcement Report: 7/31/02 Class: II PRODUCT Intera 1.0T and 1.5T MR Systems Magnetic Resonance Systems are indicated for use as diagnostic devices that display the internal structure and/or function of the head, body or extremeties. The coils are used to obtain optimal imaging. Recall # Z-1147-2/Z-1148-2. REASON Higher than...
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Company: Baxter Healthcare CorpDate of Enforcement Report: 7/31/02 Class: II PRODUCT Baxter Ipump Pain Management System infusion pump, product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1166-2. REASON Software anomaly allows access to change prescription or program bolus without security. CODE Product codes 2L3107 and 2L3107R, all serial numbers. RECALLING FIRM/MANUFACTURER...
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Company: Semens Medical SystemsDate of Enforcement Report: 7/31/02 Class: II PRODUCT SONOLINE Antares, Diagnostic Ultrasound System. The SONOLINE Antares is a high-resolution, digital, broadband diagnostic ultrasound imaging system. It supports the following diagnostic applications: abdominal, OB/GYN, small parts, musculoskeletal, vascular, and urology. Recall # Z-1162-2. REASON Software anomalies that affect measurement and calculation data. CODE...
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Company: Earlham CollegeDate: 07/29/2002 Product: Prenatal vitamins In addition to the above listed violations, our Investigator noted that the laboratory is using an electronic record system for processing and storage of data from the atomic absorption and HPLC instruments that is not set up to control the security and data integrity in that the system...
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Company: Fresenius Medical CareDate: 7/25/02 Product: Naturalyte Acid Concentrate Your firm failed to validate the new salt delivery system for process deviation 2002-005 dated February 1, 2002 for Naturalyte Acid Concentrate lot 2B0017 as required by 21 CFR 820.75. Furthermore, the new computer software included with the new salt delivery system is not validated for...
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Company: Abbott LaboratoriesDate: 7/19/02 Product: Drug products including Biaxin and Meridia FDA compared the MedWatch forms in your computer to your paper files, and this comparison revealed inaccurate data in serious and unexpected adverse drug experience reports submitted to FDA. These inaccurate reports are a violation of 21 CFR 314.80(c)(1)(i). FDA District: Chicago District Office
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Company: Varian Medical Systems, Inc Date of Enforcement Report: 7/3/2002 Class: II PRODUCT Varian Medical System’s Eclipse VERSION 6.5 software, a proprietary application for Varian Vision ™ imaging systems. Recall # Z-1109-2. REASON Radiation treatment planning software malfunction could result in incorrect treatment regimen. CODE Eclipse software, version 6.5, Serial Numbers: 0016 0018 0022 0034...
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Company: Philips Medical SystemsDate of Enforcement Report: 7/3/2002 Class: II PRODUCT Information Center System and Upgrades as follows: a) M3150A Agilent or Virida Information center. Recall # Z-1119-2; b) M3151A Agilent or Virida Information Center Client. Recall # Z-1120-2; c) M3153A Agilent or Virida Surveillance Center. Recall # Z-1121-2; d) M3150AU#A01 Agilent or Virida Information...
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Company: Toshiba America Medical Systems, IncDate of Enforcement Report: 6/26/02 Class: II PRODUCT NEMIO, SSA550A, Diagnostic Ultrasound System. Recall # Z-0923-2. REASON Software anomally caused error in calculating VM_P. CODE Serial Numbers: B1552349 C1572413 C1572414 C1572415 C1572417 C1572418 C1572420 C1572423 C1572428 C1572429 C1572430 C1572431 C1572432 C1572433 C1572421. RECALLING FIRM/MANUFACTURER Toshiba America Medical Systems, Inc., Tustin,...
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483Company: American Red Cross City and Sate: Baltimore, MD FDA District: Baltimore, MD Dates of Inspection: 4/22-6/21/02 4. Failure of the quality control unit to determine root cause and prevent recurrence of significant deviations related to BSD 73.200M, “Shipping” version 1.7 January 2001. Between October 22, 2001 and April 23, 2002, the Chesapeake Region recorded...
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Company: Advanced Sterilization ProductsDate: 6/19/2002 Class: II PRODUCT STERRAD 100S Sterilization System. Recall # Z-1082-2. REASON Software anomaly allows half cycle run when full cycle displayed. CODE Version 3 or lower is subject to upgrade. Newer versions contain software “fix”. Current version is Version 6. RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA, by letters sent...
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/docs/NEMAPart11DraftValidationGuidanceComments.pdf
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Company: Fujifilm Medical Systems U.S.ADate of Enforcement Report: 5/29/02 Class: II PRODUCT Synapse Image and Information Management System. Recall # Z-1045-2. REASON Rotated/flipped Images not viewed on the screen may not rotate but left / right markers will be flipped. CODE Synapse Image and Information Management System with software versions 2.0.2 and 2.1.1. RECALLING FIRM/MANUFACTURER...
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Company: Liebel-Flarsheim CoDate of Enforcement Report: 5/29/2002 Class: II PRODUCT Liebel-Flarsheim Angiomat Illumena Media Power Injectors, P/N 900001, using Version 8.0 software with new console. Recall # Z-1046-2. REASON Pushing the scoll button repeatedly / rapidly results in erroneous protocol ID. CODE Serial Numbers: 0202-5000 to 0402-5126. RECALLING FIRM/MANUFACTURER Recalling Firm: Mallinckrodt, Inc. / Liebel-Flarsheim...
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