Tag

recall

Software Recall

Company: Varian Medical Systems, Inc. Date of Enforcement Report: 5/13/2020 Class II PRODUCT Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 – Product Usage: is intended to assist the clinician in the delivery of external beam...
Read More
Company: Cuattro LLC Date of Enforcement Report: 5/20/2020 Class II PRODUCT CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0 Recall Number: Z-1934-2020 REASON There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient. RECALLING FIRM/MANUFACTURER Cuattro LLC...
Read More
Company: The Binding Site Group, Ltd. Date of Enforcement Report: 6/10/2020 Class II PRODUCT The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 – Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on...
Read More
Company: Immersivetouch Inc Date of Enforcement Report: 6/10/2020 Class II PRODUCT ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options Recall Number: Z-2041-2020 REASON Observed an internal repetitive software glitch in ImmersiveView. RECALLING FIRM/MANUFACTURER Immersivetouch Inc on 4/3/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME...
Read More
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation)...
Read More
Company: Inpeco S.A. Date of Enforcement Report: 6/10/2020 Class II PRODUCT FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory....
Read More
Company: Medtronic Inc. Date of Enforcement Report: 6/10/2020 Class II PRODUCT Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices. Recall Number: Z-2106-2020 REASON Customers using the firm’s continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12,...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 6/10/2020 Class II PRODUCT System, Tomography Computed Emmission Recall Number: Z-2258-2020 REASON GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic...
Read More
Company: ICU Medical, Inc. Date of Enforcement Report: 5/13/2020 Class II PRODUCT The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 – Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and...
Read More
Company: Elekta Inc Date of Enforcement Report: 5/7/2020 Class II PRODUCT Elekta MONACO RTP Sytem, radiation treatment planning software system – Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number: Z-1803-2020 REASON The Monaco RTP Radiation Treatment Planning System may change the...
Read More
Company: Viewray, Inc. Date of Enforcement Report: 5/7/2020 Class II PRODUCT ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software Recall Number: Z-1803-2020 REASON Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered...
Read More
Company: Philips North America, LLC Date of Enforcement Report: 5/7/2020 Class II PRODUCT Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079 Recall Number: Z-1809-2020 REASON When a user acquires XperCT scan on an Azurion 2.0 system, enters the...
Read More
Company: ICU Medical, Inc. Date of Enforcement Report: 5/7/2020 Class II PRODUCT ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499 Recall Number: Z-1835-2020 REASON Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of...
Read More
Company: Boston Scientific Corporation Date of Enforcement Report: 5/7/2020 Class II PRODUCT iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System Recall Number: Z-1804-2020 REASON Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 5/7/2020 Class II PRODUCT Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower Recall Number: Z-1797-2020 REASON Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on...
Read More
Company: Obalon Therapeutics Inc Date of Enforcement Report: 5/7/2020 Class II PRODUCT Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 – Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the...
Read More
Company: Radiometer Medical ApS Date of Enforcement Report: 4/29/2020 Class II PRODUCT TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) – Product Usage: It is indicated for use on pediatrics and adults. Recall Number: Z-1755-2020 REASON Reports have...
Read More
Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report: 4/29/2020 Class II PRODUCT Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX;...
Read More
Company: Philips North America, LLC Date of Enforcement Report: 4/29/2020 Class II PRODUCT TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861 Recall Number: Z-1766-2020 REASON The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed...
Read More
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...
Read More
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...
Read More
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,...
Read More
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...
Read More
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...
Read More
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...
Read More
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)....
Read More
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....
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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,...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
1 2 3 4 57

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.