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Company: Medical Intelligence Medizintechnik Gmbh Date of Enforcement Report: 7/31/2019 Class II PRODUCT IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. Recall Number: Z-2082-2019 REASON Sometimes, although the...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 7/31/2019 Class II PRODUCT Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Recall Number: Z-2062-2019 REASON Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation...
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Company: GE Healthcare, LLC Date of Enforcement Report: 7/31/2019 Class II PRODUCT MAC VU360, Model Number 2030360-001, Electrocardiograph Recall Number: Z-2060-2019 REASON Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report...
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Company: Stanley Security Solutions Inc Date of Enforcement Report: 7/31/2019 Class II PRODUCT STANLEY Healthcare Arial 54315 Network Manager Recall Number: Z-1996-2019 REASON STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been traced back to the Arial¿ 54315 Serial-to-IP Network Gateway. RECALLING FIRM/MANUFACTURER Stanley Security Solutions Inc...
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Company: GETINGE US SALES LLC Date of Enforcement Report: 7/31/2019 Class II PRODUCT PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the...
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Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 7/31/2019 Class II PRODUCT Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. Recall Number: Z-2035-2019 REASON Several reports were received that patient records were printed with the correct patient demographics but containing another patient’s waveforms. RECALLING FIRM/MANUFACTURER Spacelabs Healthcare,...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 7/31/2019 Class II PRODUCT BrightView SPECT, Model Number 882480 Recall Number: Z-2009-2019 REASON An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc. on 6/10/2019. Voluntary:  Firm Initiated...
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During an inspection of your firm located in Tuttlingen, Germany, on January 25, 2012, through January 27, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-powered endoscopic grasping/cutting instruments. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these...
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Company: Elekta, Inc. Date of Enforcement Report: 7/24/2019 Class II PRODUCT Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 7/24/2019 Class II PRODUCT Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network...
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Company: Canon Medical System, USA, INC. Date of Enforcement Report: 7/17/2019 Class II PRODUCT Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on...
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Cybersecurity issues arise when medical devices are capable of connecting to the Internet or other medical devices. Since the FDA is concerned with regulating the safety and effectiveness of medical devices, manufacturers must ensure that the computer systems of medical devices are protected against security breaches. The link below provides the FDA Fact Sheet entitled,...
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Company: Hamilton Medical Date of Enforcement Report: 7/12/2019 Class I PRODUCT Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001) Recall Number: Z-1874-2019 REASON New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted....
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Company: Hitachi America, Ltd., Power Systems Division Date of Enforcement Report: 7/3/2019 Class II PRODUCT PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. Recall Number: Z-1892-2019 REASON There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy...
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Company: GE Healthcare, LLC Date of Enforcement Report: 7/3/2019 Class II PRODUCT Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored,...
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Patient Engagement Advisory Committee Meeting to Discuss Cybersecurity – September 10, 2019 On September 10, 2019 the FDA will hold a meeting of the Patient Engagement Advisory Committee. The committee provides advice to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. During the meeting the...
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Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required (MDA/2019/024) Summary Manufactured by B. Braun Avitum AG – Malfunction of the temperature sensor can result in temperature of the dialysis fluid to be more than ±1°C outside the programmed values, which can lead to inadequate treatment....
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Join the FDA and NITRD on July 17 for a Listening Session on Interoperability of Medical Devices On July 17, 2019, the U.S. Food and Drug Administration (FDA) and The Networking and Information Technology Research and Development Program (NITRD) will host a listening session on the interoperability of medical devices, data and platforms. During the...
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The FDA is warning patients and health care providers that certain Medtronic MiniMed™ insulin pumps have potential cybersecurity risks. Patients with diabetes using these models should switch their insulin pump to models that are better equipped to protect against these potential risks.
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Company: GE Healthcare, LLC Date of Enforcement Report: 6/26/2019 Class II PRODUCT LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM,...
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Company: Monarch Medical Technologies Date of Enforcement Report: 6/26/2019 Class II PRODUCT Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10. Recall Number: Z-1786-2019 REASON Insulin dosing calculations were erroneously high. RECALLING FIRM/MANUFACTURER Monarch Medical Technologies on 5/3/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Arkray Factory USA, Inc. Date of Enforcement Report: 6/26/2019 Class II PRODUCT AUTION HYBRID AU-4050 Recall Number: Z-1850-2019 REASON This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to...
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May and June 2019 was a busy period for software related recalls – there were 28 recalls as you will see later in the Newsletter. As you plan your software quality assurance activities, we encourage review of published recalls and consider what steps you have in your process to prevent similar problems. Onward toward higher...
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The US Defense Advanced Research Projects Agency (DARPA) have released a solicitation for the “Automated Rapid Certification of Software (ARCOS)” project.  The project goal is to automate system risk assessment based on software assurance.  The project recognizes that current practices in this area rely upon human judgement which can be prone to error but also...
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Company: GE Healthcare, LLC Date of Enforcement Report: 6/19/2019 Class II PRODUCT GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x Recall Number: Z-1781-2019 REASON There is a potential that one or more image series (i.e., all images within an image...
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Company: Philips North America, LLC Date of Enforcement Report: 6/19/2019 Class III PRODUCT Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the...
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Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report: 6/19/2019 Class II PRODUCT Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass. Recall Number: Z-1769-2019 REASON An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration...
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Company: Conformis, Inc. Date of Enforcement Report: 6/19/2019 Class II PRODUCT Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT) Recall Number: Z-1775-2019 Recall Number: Z-1776-2019 REASON Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. RECALLING...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 6/19/2019 Class II PRODUCT InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim...
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Company: One Lambda Inc Date of Enforcement Report: 6/19/2019 Class II PRODUCT UniMatch Plus Software (Catalog ID 790111 and A10286, Version 6.0) when used in association with CHR_005_201807v1.uch Recall Number: B-0675-2019 REASON The UniMatch Plus Software, containing incorrect allele specificity information, which may result in an ambiguous result or a mistyping, was distributed. RECALLING FIRM/MANUFACTURER...
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Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report: 6/12/2019 Class III PRODUCT 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 – Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Recall Number: Z-1699-2019 REASON Power Logic Board Fail Message on the...
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Company: Philips North America, LLC Date of Enforcement Report: 6/12/2019 Class II PRODUCT IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 – Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected...
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Company: Flowonix Medical Inc Date of Enforcement Report: 6/12/2019 Class II PRODUCT Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. Recall Number: Z-1712-2019 Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For...
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Advanced Botanical Consulting & Testing Inc dba ABC Testing Product: Drugs Date: 6/11/19 CMS Number: 572991 The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Advanced Botanical Consulting and Testing Inc. dba ABC Testing (FEI 3003693795) at 1169 Warner Ave, Tustin, California, from November 1 to 13, 2018. This warning letter summarizes...
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Company: Abbott Laboratories Inc. (St Jude Medical) Date of Enforcement Report: 6/5/2019 Class II PRODUCT TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) Recall Number: Z-1493-2019 REASON In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the...
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Company: Change Healthcare Israel Ltd. Date of Enforcement Report: 6/5/2019 Class II PRODUCT Horizon Cardiology Hemo: Software version 11.x and 12.x Recall Number: Z-1489-2019 Software version 13.x Recall Number: Z-1490-2019 REASON Users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 5/29/2019 Class I PRODUCT UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per...
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Company: Neusoft Medical Systems Co., Ltd. Date of Enforcement Report: 5/29/2019 Class II PRODUCT NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by...
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Company: KaVo Dental Technologies LLC Date of Enforcement Report: 5/29/2019 Class II PRODUCT DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform...
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Company: Elekta Instrument AB Date of Enforcement Report: 5/29/2019 Class II PRODUCT Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. Recall Number: Z-1412-2019 REASON The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. RECALLING FIRM/MANUFACTURER Elekta Instrument AB...
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Company: Roche Diagnostics Corporation Date of Enforcement Report: 5/29/2019 Class II PRODUCT Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use Recall Number: Z-1368-2019 REASON Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to...
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Company: Philips North America, LLC Date of Enforcement Report: 5/22/2019 Class II: PRODUCT SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Recall Number: Z-1317-2019 SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Recall Number: Z-1318-2019 SureSigns...
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Company: Becton Dickinson & Co. Date of Enforcement Report: 5/22/2019 Class II: PRODUCT BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066 Recall Number: Z-1313-2019 BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055 Recall...
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Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 5/22/2019 Class II: PRODUCT Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN...
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FDA announced the next phase of its Pre-Cert Test Plan implementation. Pre-Cert refers to the the pre-certification program that FDA’s Digital Health unit has been piloting. The program targets SaMD devices only at this time. This next phase seeks SaMD companies, willing to volunteer, that foresee a De Novo request or 510(k) submission within the...
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COURSE DATES: June 4 – 6, 2019 TRAINING LOCATION: Boston, MA USA COST: 3 Full Days for $2,495.00 (Registration closes 5/30/2019) Get 24% off for 4 or more from same company registering with same payment! Registration link: https://events.eventzilla.net/e/62304-and-emerging-software-standards-training-course-2138720953 This three-day course provides a clear understanding of the 62304 standard for medical device software, FDA expectations...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 5/15/2019 Class II PRODUCT Atellica IM 1300 Analyzer, Material Number 11066001; Recall Number: Z-1299-2019 Atellica IM 1600 Analyzer, Material Number 11066000; Recall Number: Z-1300-2019 Atellica Sample Handler Prime, Material Number 11069001; Recall Number: Z-1301-2019 REASON There were multiple issues identified in the system software which required...
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Company: Medtronic Inc. Date of Enforcement Report: 5/15/2019 Class II: PRODUCT Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. Recall Number: Z-1282-2019 REASON The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the...
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Zeller Power Products, LLC Product: Medical Device Date: 5/9/19 CMS Number: 570909 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Zeller Power Products, LLC., located at 6585 Arville Street, Suite A, Las Vegas, NV, from November 6 – 9, 2018. During the inspection, an FDA investigator...
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Rechargeable Power Energy North America, LLC Product: Medical Device Date: 5/9/19 CMS Number: 570911 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Rechargeable Power Energy North America, LLC located in Las Vegas, Nevada, from November 5 – 9, 2018. During the inspection, an FDA investigator determined...
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