Tag

recall

Software Recall

Company: Synaptive Medical Inc. Date of Enforcement Report: 4/29/2020 Class II PRODUCT ClearCanvas RIS/PACS Recall Number: Z-1758-2020 REASON A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. RECALLING FIRM/MANUFACTURER Synaptive Medical Inc. on 2/26/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 4/29/2020 Class II PRODUCT Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352. Recall Number: Z-1741-2020 REASON Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused...
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Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 4/22/2020 Class II PRODUCT Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 – Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization,...
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Company: Abbott Date of Enforcement Report: 4/22/2020 Class II PRODUCT Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads. Recall Number: Z-1700-2020 REASON...
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Company: Sysmex America, Inc. Date of Enforcement Report: 4/22/2020 Class II PRODUCT The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back...
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Company: Canon Medical System, USA, INC. Date of Enforcement Report: 4/22/2020 Class II PRODUCT Canon Aquilion Lightning, Model TSX-036A Recall Number: Z-1719-2020 REASON Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the...
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Company: Radiometer Medical ApS Date of Enforcement Report: 4/15/2020 Class II PRODUCT ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF)....
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/15/2020 Class II PRODUCT ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 Recall Number: Z-1677-2020 REASON Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy....
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Company: Change Healthcare Canada Company Date of Enforcement Report: 4/15/2020 Class II PRODUCT McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management Recall Number: Z-1682-2020 REASON Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format. RECALLING FIRM/MANUFACTURER Change Healthcare...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 4/15/2020 Class II PRODUCT LabPro Data Management System, UDI: 15099590676872 – Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually...
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Company: Ra Medical Systems, Inc. Date of Enforcement Report: 4/8/2020 Class II PRODUCT Pharos Excimer Laser, Model: EX-308 – Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region...
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Company: Haemonetics Corporation Date of Enforcement Report: 4/8/2020 Class II PRODUCT TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies Recall Number: Z-1617-2020 REASON Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to...
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Company: Intellijoint Surgical, Inc. Date of Enforcement Report: 4/1/2020 Class II PRODUCT Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) – Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to...
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Company: Hill-Rom Inc. Date of Enforcement Report: 4/1/2020 Class II PRODUCT NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0) Recall Number: Z-1554-2020 REASON...
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Company: Insulet Corporation Date of Enforcement Report: 4/1/2020 Class II PRODUCT Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 – M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH...
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Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 4/1/2020 Class II PRODUCT LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module. Recall Number: Z-1580-2020 REASON Abbott has identified potential performance issues for the Alinity ci...
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Company: LivaNova USA Inc Date of Enforcement Report: 4/1/2020 Class II PRODUCT VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. Recall Number: Z-1563-2020 REASON False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current,...
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Company: QUIDEL CARDIOVASCULAR INC Date of Enforcement Report: 4/6/2020 Class II PRODUCT Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com Recall Number: Z-1552-2020 REASON Due to an error...
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Company: Boston Scientific Corporation Date of Enforcement Report: 3/25/2020 Class II PRODUCT Boston Scientific, LATITUDE Programming System, Model 3300 – Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/25/2020 Class II PRODUCT Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and...
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Company: CME America, LLC Date of Enforcement Report: 3/25/2020 Class I PRODUCT CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG CV545, BG CV575, and CMExpress Recall Number: Z-1474-2020 REASON Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/25/2020 Class II PRODUCT Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system. Recall Number: Z-1501-2020 REASON The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal...
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Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 3/25/2020 Class II PRODUCT Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT. Recall Number: Z-1524-2020 REASON Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the...
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Company: Braemar Manufacturing, LLC Date of Enforcement Report: 3/26/2020 Class II PRODUCT Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only. Recall Number: Z-1459-2020 REASON An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the...
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Company: Randox Laboratories, Limited Date of Enforcement Report: 3/11/2020 Class II PRODUCT RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) – Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories. Recall Number: Z-1349-2020 REASON Software version UI2550642107 for...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 3/11/2020 Class II PRODUCT Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower – Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology...
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Company: Advanced Bionics, LLC Date of Enforcement Report: 3/11/2020 Class III PRODUCT SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 – Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device...
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Company: Tosoh Bioscience Inc Date of Enforcement Report: 3/11/2020 Class II PRODUCT AIA-360 Automated Immunoassay Analyzer, Product Code 019945 Recall Number: Z-1420-2020 REASON A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 3/11/2020 Class I PRODUCT CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) Recall Number: Z-1359-2020 REASON 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping...
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Company: Vyaire Medical Date of Enforcement Report: 2/26/2020 Class II PRODUCT Bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the...
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Company: Normand-Info S.A.S.U. Date of Enforcement Report: 3/11/2020 Class II PRODUCT Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems. Recall Number: Z-1430-2020 REASON A patch was released for a critical remote code execution vulnerability in remote desktop services. This vulnerability can be exploited remotely...
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Company: Philips North America, LLC Date of Enforcement Report: 3/3/2020 Class II PRODUCT Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: – 453564067151 24-Hour Configuration – 453564067161 48-Hour Configuration – 453564067171 96-Hour Configuration...
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Company: St Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report:3/3/2020 Class II PRODUCT Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330 Recall Number: Z-1351-2020 REASON Past updates to programmers and transmitters may lead some implantable...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/3/2020 Class II PRODUCT COHERENCE Oncologist, Model Nos. 07333680 & 07351898 Recall Number: Z-1346-2020 REASON A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 2/26/2020 Class II PRODUCT Luminos dRF Max, model no. 10762471 – Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal,...
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Company: Philips Medical Systems Gmbh, DMC Date of Enforcement Report: 2/26/2020 Class II PRODUCT CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 – Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. Recall Number: Z-1328-2020 REASON When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state,...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 2/26/2020 Class II PRODUCT ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator – product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay. Recall Number: Z-1260-2020 REASON Atellica and ADVIA hsCRP calibrator accuracy has drifted away...
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Company: Philips Respironics, Inc. Date of Enforcement Report: 2/26/2020 Class I PRODUCT Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. Recall...
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Company: Degania Silicone, Ltd. Date of Enforcement Report: 1/22/2020 Class II PRODUCT Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage. Recall Number: Z-0809-2020 REASON Temperature deviation did not meet release specifications. RECALLING FIRM/MANUFACTURER Degania Silicone,...
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Company: St Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report: 1/22/2020 Class II PRODUCT Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. – Product Usage:...
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Company: GE Healthcare, LLC Date of Enforcement Report: 1/22/2020 Class I PRODUCT CARESCAPE Respiratory Module E-sCO Recall Number: Z-0754-2020 CARESCAPE Respiratory Module E-sCOVX Recall Number: Z-0755-2020 CARESCAPE Respiratory Module E-sCAiO Recall Number: Z-0756-2020 CARESCAPE Respiratory Module E-sCAiOV Recall Number: Z-0757-2020 CARESCAPE Respiratory Module E-sCAiOE Recall Number: Z-0758-2020 CARESCAPE Respiratory Module E-sCAiOVE Recall Number: Z-0759-2020 Airway...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 1/1/2020 Class II PRODUCT RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 – Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment...
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Company: GE Healthcare, LLC Date of Enforcement Report: 1/1/2020 Class II PRODUCT ApexPro Telemetry System – Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system...
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Company: LivaNova USA Inc Date of Enforcement Report: 1/1/2020 Class I PRODUCT VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy Recall Number: Z-0561-2020 REASON Certain Model 1000 generators (SN = 100,000) have experienced unexpected device resets, which resulted in disablement of therapy. Fourteen (14) complaints have been reported....
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Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 12/25/2019 Class II PRODUCT VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of...
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Company: GE Healthcare, LLC Date of Enforcement Report: 12/25/2019 Class II PRODUCT Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571 Recall Number: Z-0114-2020 REASON Certain Aespire and Aestiva Anesthesia Systems were...
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 12/16/2019 Class I PRODUCT Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs. Recall Number: Z-0610-2020 REASON There is an anomaly in...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/20/2019 Class II PRODUCT Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and...
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Company: Draegar Medical Systems, Inc. Date of Enforcement Report: 11/20/2019 Class II PRODUCT Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 Recall Number: Z-0372-2020 REASON The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. RECALLING FIRM/MANUFACTURER Draegar...
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Company: Abiomed, Inc. Date of Enforcement Report: 11/13/2019 Class II PRODUCT lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI Recall Number: Z-0345-2020 REASON This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would...
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