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imaging
Company: Hitachi Medical Systems America Inc. Date of Enforcement Report:10/18/2006 Class:ll PRODUCT MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007 REASON Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol,...
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Company: Hitachi Medical Systems America, Inc., Date of Enforcement Report:6/21/2006 Class:lI PRODUCT Altaire Nuclear Magnetic Resonance Imaging Device Systems, Recall # Z-1104-06 REASON Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result...
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Company:Hitachi Medical Systems America, Inc.Date of Enforcement Report:6/7/2006 Class:lI PRODUCT Magnetic Resonance Imaging Device, Recall # Z-0910-06 REASON The device has a software anomaly which causes the operating system to lock up and data to become corrupted during service procedures. CODE L001-L223 C002-C765 Hoo2-H733 RECALLING FIRM/MANUFACTURER Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH,...
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Company: Philips Medical Systems Inc., Date of Enforcement Report:5/31/2006 Class:lI PRODUCT Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images. Software version 1.0 or 1.0.1, Recall # Z-0889-06 REASON Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report:5/3/2006 Class:lI PRODUCT AXIOM Artis X-ray systems running software versions VB11K and VB22-G, AXIOM Artis FC model number 5904433, AXIOM Artis BC model number 5904649, AXIOM Artis MP model number 5904466, AXIOM Artis FA model number 5904441, AXIOM Artis BA model number 5904656, AXIOM Artis TC...
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Company: Boston Scientific Target, Date of Enforcement Report:3/15/2006 Class:lI PRODUCT ILab Utrasound Imaging System, software controlled Imaging Catheter, Model Numbers M0004EPiL120CART0, H749iLab120CART0, H749iLab120CARTD0, H749iLab120CARTR0, H749iLab120INS0, Recall # Z-0789-06 REASON Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters...
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Company: Toshiba America Medical Systems, Inc., Date of Enforcement Report:3/8/2006 Class:Il PRODUCT Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film device for diagnostic fluoroscopic imaging, Recall # Z-0533-06 REASON Systems are defective under 21 CFR 1003.2 in that they may deliver radiation unintended to their use. CODE Serial numbers D4622390, D4622394, D4623349, D4612382,...
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Company: Philips Medical Systems North America Co.Date of Enforcement Report:1/18/2006 Class:lI PRODUCT Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. Recall # Z-0358-06 REASON The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient’s image record.....
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Company: Biosound Esaote, IncDate of Enforcement Report: 9/7/05 Class:II PRODUCT a) MyLab30CV Ultrasound Imaging System; model 9807300000, Recall # Z-1401-05; b) MyLab30CV Ultrasound Imaging System; model 9807300001, Recall # Z-1402-05; c) MyLab25 Ultrasound Imaging System; model 9807300002, Recall # Z-1403-05 REASON Data maybe corrupted upon re-opening archived files. CODE a) All units using software version...
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Company: Toshiba American Med Systems, IncDate of Enforcement Report: 7/20/05 Class: II PRODUCT Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart Vantagae, Recall # Z-0986-05 REASON Patient information A is displayed with images of patient B. CODE All codes RECALLING FIRM Recalling Firm: Toshiba American Med...
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Recipient: Hitachi Medical Systems America Inc.Product: Magnetic Resonance Imaging Systems Date: 7/13/05 On April 20, 2004, your firm issued a Software Release Bulletin instructing the service representatives to install a software upgrade to all Altaire/AIRIS MRI systems. This upgrade fixed the problem of images from one patient’s study being co-mingled with another patient’s study. Your...
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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...
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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...
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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,...
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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,...
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Company: Inceptio Medical Technologies LCProduct: “Punctsure Vascular Access Imaging Procedure Kits” and other ultrasonic vascular imaging systems and sterile accesories Date: 7/14/04 Failure to validate a process for which results cannot be fully verified by subsequent inspection or test, [21 CFR 820.75(a)]. Your sterilization process validation for the Punctsure Vascular Access Imaging Procedure Kits is...
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Company: Toshiba American Med Sys IncDate of Enforcement Report: 5/12/04 Class: III PRODUCT Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. Recall # Z-0937-04. REASON Software anomaly. The region of the...
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Company:Toshiba American Med SysDate of Enforcement Report: 3/10/04 Class: III PRODUCT Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models. Recall # Z-0546-04. REASON Software anomally causes image slices to be in incorrect order. CODE Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with software V4.04*R251 to...
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Company: Ocuserv Instruments Inc.Product: Ultrasonic Imaging Systems, Autoscan DB 3000, DB 3000C Biometric Rulers and Ophthalmic A-Scan Systems Date: 3/2/04 During an inspection of your firm located in Jamaica, New York, conducted during the dates of January 13, 14 & 23, 2004, our investigator determined that your firm manufactures medical devices under the brand names...
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Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 12/24/03 Class: II PRODUCT Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade. Model numbers 4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971, and...
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Company: Varian Brachytherary VirginiaDate of Enforcement Report: 12/17/03 Class: II PRODUCT BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Recall # Z-0176-04. REASON The manufacturer’s instructions for using radiation treatment software may cause healthcare practitioner to administer an incorrect treatment to...
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Company: Siemans Medical Solutions USA, IncDate of Enforcement Report: 7/23/03 Class: II PRODUCT Acuson Cypress Echocardiography System, Imaging System. Catalog # 8264604. Recall # Z-0975-03. REASON Software problem – loss of data. CODE Serial numbers 70000 through 72000. RECALLING FIRM/MANUFACTURER Siemans Medical Solutions USA, Inc., Plymouth Meeting, PA, by letter dated April, 2003. Firm initiated...
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Company:Canon USA, Inc.Date of Enforcement Report: 6/25/03 Class: II PRODUCT Rational Imaging TM Software, model Ultra 10 PACS System. Recall # Z-0905-03. CODE RIUpdate 7.1.OK. RECALLING FIRM/MANUFACTURER Canon USA, Inc., Irvine, CA, by letters on March 11, and March 26, 2003. Firm initiated recall is ongoing. REASON Imaging archive system software mismatches images and patient...
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Company: MagneVu Product: Portable magnetic resonance imaging (MRI) system Date: 07/11/03 Software validation activities for computers or automated data processing systems used as part of production have not been performed or documented [21 CFR 820.70(i)]. Specifically, the Eng MagMRI software used for engineering and servicing of the MagneVu 1000 MRI System has not been validated....
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Company: Siemens Medical Solutions USA, IncDate of Enforcement Report: 5/28/03 Class: II PRODUCT a) Leonardo MM-WS systems. System, Image Processing. Recall # Z-0841-03; b) Smatom Sensation 16, Computed Tomography System, Diagnostic Imaging. Recall # Z-0842-03. REASON Perfusion CT is displaying a higher gray and color values than normal. A software problem. CODE a) Model Number...
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Company: Siemens Medical SolutionsDate of Enforcement Report: 4/30/03 Class: III PRODUCT ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems. Recall # Z-0727-03. REASON ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions. CODE All Diacam, Multispect...
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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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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: 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: 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: 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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/docs/NEMAPart11DraftValidationGuidanceComments.pdf
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A NEMA paper on HIPAA is available here:  NEMA HIPAA Security Intro Overview. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was signed to law on July 21, 1996, and has the general objectives to: Guarantee health insurance coverage of employees Reduce health care fraud and abuse Introduce/implement administrative simplifications in order to augment...
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Company: Siemens Medical Systems, IncDate of Enforcement Report: 1/16/02 Class: III PRODUCT Autoperfusion Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0427-02. REASON The software did not save oblique data correctly...
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Company: Siemens Medical Systems, INCDate of Enforcement Report: 11/16/01 Class: III PRODUCT Autoperfusion Software, which includes The Cardiac Review (Profile Review) application, used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems to conduct automated myocardial processing in diagnosing myocardial disease in cardiac SPECT studies. Recall # Z-0428-02. REASON...
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Company: Siemens Medical Systems, IncDate of Enforcement Report: 10/24/01 Class: III RECALL NUMBER, PRODUCT AND CODE: Z-0031-2, Motion Electronics Computer Chassis (MECC) Backplanes installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL Codes: MECC Backplane “2104938 REV C” —...
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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...
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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...
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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...
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Date of enforcement report: 2/28/01Date of recall: 9/12/00 Company: Escreen Inc. Class: II PRODUCT: EScreen System, which collectively includes the eCUP, the eREADER optical imaging technology, and the eCUP data analysis software, for use in drug abuse testing. Recall #Z-205-1. REASON: Distributed without 510(k) clearance. CODE: All. MANUFACTURER: EScreen Inc., Overland Park, KS. RECALLED BY:...
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PRODUCT Magnetom 42 SP Magnetic Resonance Imaging System with Software Version Number 2A2.7B. Computer aided medical device generates magnetic field resulting in a digital image of the body: a) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 89 69 131 (SP-A); b) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 87-29-485 (SP). Recall...
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REASON Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter. PRODUCT Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI. Recall #Z-412-0. CODE Serial Numbers: AF212E, BA109P, BA218P, BA103P, AF165E, AF157EU, BA183P, BA118P, BA182P, BA164D, BA178P, BA114P, BA225P, BA187P, AF113EU, BB104P, BA110P, BA131D, and BA192D. MANUFACTURER...
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Four Recalls of Picker International Nuclear Cameras and imaging systems12/15/98 Prism XPVT 63 units. Unexpected camera movement which requires the operator to power down and reboot with delay in diagnosis. Z-643/650-9 11/18/98 Model 3000 325 units. Unintended motion of gantry during setup. Z-641/642-9 11/17/98 ModelFX AND fx 800 WITH VERSION 8.3.11 software. 70 units. Software...
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7/20/98 Hewlett Packard Image Point Ultrasound System Model 2410A used in ultrasound imaging to determine stenosis of the sarotid artery. Software Revisions A.0.0 A.0.1, and A.0.1.2. Class II 441 units. Software overestimates peak blood velocity by 15-25% in some Doppler examinations with the Model 2135A transducer. Recall #=Z-160-8.
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