Guiding clients to effective and efficient compliance and regulatory approvals

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...
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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;...
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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...
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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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FDA released a new guidance document titled, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments, Guidance for Industry and Food and Drug Administration Staff.  This guidance was issued on April 22, 2020.  The background on the guidance states, “Timely nonbinding feedback can help device firms determine whether proposed actions to address inspectional observations are...
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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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U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID- 19) Public Health Emergency.  FDA believes the policy set forth in this guidance may help address these urgent public health concerns by helping to expand the availability and remote capabilities...
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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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On February 25-26, 2020 the U.S. Food and Drug Administration (FDA) held a public workshop to discuss the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The comment period for the public workshop is extended to June 30, 2020, in response to requests for an extension to allow stakeholders additional time to submit comments.
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Today (25 March 2020), the Commission announced that work on a proposal to postpone the date of application for the Medical Device Regulation (MDR) for one year is ongoing. The decision was reached with patient health and safety as a guiding principle.  
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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