By

Jordan Pate
FDA announces a new pilot program to simplify certain 510(k)s. For more information on eligibility click the link and scroll to near the bottom of the page.  
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Two webinars will be held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health Informatics, as well as the Member Bodies of ISO/TC 210, Quality management and corresponding general aspects for medical devices. These webinars are being held to explain the status of the IEC 62304 project. A committee...
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Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report: 9/26/2018 Class II: PRODUCT 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy Recall Number: Z-3194-2018 REASON In the hemodialysis machine during the cleaning/disinfection...
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Company:Mako Surgical Corporation Date of Enforcement Report 9/26/2018 Class lI: PRODUCT Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and...
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Company:Mobius Imaging, LLC.. Date of Enforcement Report 9/26/2018 Class II: PRODUCT AIRO Mobile CT System Model # Mobi CT-32 Recall Number: Z-2991-2018 REASON The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is...
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For a quick and easy way to find US regulations, including those related to FDA, click the link provided.  
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To search FDA MDRs, click the link provided.  
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Company: Hitachi Healthcare Americas Corp Informatics Division. Date of Enforcement Report 9/12/2018 Class II: PRODUCT VidiStar(TM) PACS & DICOM Viewer Software system. Recall Number: Z-2992-2018 REASON The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study....
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Company:Canon Medical System, USA, INC. Date of Enforcement Report 9/12/2018 Class II: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2964-2018 REASON It was found when an operator performs a radiography using the wireless flat panel detector...
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Company: Ortho Kinematics, Inc Date of Enforcement Report 8/29/2018 Class II: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2882-2018 REASON Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for...
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Pharmaceutical Laboratories and Consultants, Inc. Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of...
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Company: LIEBEL-FLARSHEIM COMPANY LLC Date of Enforcement Report: 8/29/2018 Class II: PRODUCT Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. Recall Number: Z-2833-2018 REASON Software issue....
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Company: LIEBEL-FLARSHEIM COMPANY LLC Date of Enforcement Report 8/29/2018 Class II: PRODUCT Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.uch as functional x-ray diagnostics, endourology and minimal...
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Company: Spacelabs Healthcare, Ltd. Date of Enforcement Report 8/22/2018 Class II: PRODUCT Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. Recall Number: Z-2589-2018 REASON...
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Company: McKesson Israel Ltd.. Date of Enforcement Report 9/12/2018 Class II: PRODUCT McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural...
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Company: Spacelabs Healthcare, Ltd Date of Enforcement Report 8/10/2018 Class I: PRODUCT The Arkon Anesthesia Delivery System is intended for use in hospitals and operating rooms. It may be used to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits (accessory sets that include tubing and breathing bags) with...
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Yuki Gosei Kogyo Co., Ltd. Date:8/10/18 Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data. Your firm’s controls over your HPLC systems are inadequate. Some HPLC systems did not have audit trail capability or audit trails enabled....
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class II: PRODUCT SOMATOM Spirit(Model 10045692 ) Recall Number: Z-2478-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class II: PRODUCT SOMATOM Scope ( Model 10967666) Recall Number: Z-2476-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/8/2018 Class II: PRODUCT SOMATOM Scope Power (Model 10967888) Recall Number: Z-2477-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/8/2018 Class II: PRODUCT SOMATOM Perspective 16 (Model 10891666) Recall Number: Z-2475-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/8/2018 Class II: PRODUCT SOMATOM Perspective (Model 10495568) Recall Number: Z-2474-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/8/2018 Class II: PRODUCT SOMATOM Emotion 6 (Model 10165888) Recall Number: Z-2472-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/8/2018 Class II: PRODUCT SOMATOM Emotion 16 (10165977) Recall Number: Z-2473-2018 REASON A potential risk of unnecessary radiation exposure due to a software issue. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company: LivaNova USA Inc Date of Enforcement Report: 8/8/2018 Class II: PRODUCT NS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 Recall Number: Z-2572-2018 REASON Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. RECALLING FIRM/MANUFACTURER LivaNova USA Inc., Houston, TX on 7/25/2018. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...
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Company: ELITech Clinical Systems SAS Date of Enforcement Report: 8/8/2018 Class II: PRODUCT ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117 Recall Number: Z-2591-2018 REASON ELITech Clinical Systems SAS initiated this recall because some users of ENVOY...
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Company: Human Design Medical LLC Date of Enforcement Report: 8/1/2018 Class III: PRODUCT Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Recall Number: Z-2530-2018 REASON Some Vivo 65 devices have an unreleased version of the Firmware...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 7/25/2018 Class II: PRODUCT RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number: Z-2554-2018 REASON The firm has...
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Company: Forte Automation Systems Inc. Date of Enforcement Report: 8/1/2018 Class II: PRODUCT Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of...
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Company: Abbott Laboratories, Inc. Date of Enforcement Report: 8/1/2018 Class II: PRODUCT CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 Recall Number: Z-2522-2018 REASON Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems...
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FDA provides examples of cleared Mobile Medical Apps.
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Dip.io was cleared for clinical urinalysis. The device includes test strips and a color coded card that is readable by smartphone to provide a result for several conditions including infection.
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Company: Tandem Diabetes Care Inc. Date of Enforcement Report 7/25/2018 Class II: PRODUCT t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B. Recall Number: Z-2471-2018 REASON The fuel gauge, the component that reads and reports the battery parameters to the pump, could provide...
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Company: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL Date of Enforcement Report: 7/25/2018 Class II: PRODUCT T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 7/25/2018 Class II: PRODUCT RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A)Product Usage:RayStation is a software system designed for treatment planning and analysis of radiation therapy....
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Company: Intel-GE Care Innovations LLC Date of Enforcement Report: 7/25/2018 Class II: PRODUCT Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the...
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Company: Zeiss, Carl Inc. Date of Enforcement Report: 7/25/2018 Class II: PRODUCT Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope Recall Number: Z-2441-2018 REASON Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-9020-000) to activate outside of the Celldiscoverer 7 housing. This may result in exposure of the users...
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Company: Steris Corporation Date of Enforcement Report: 7/18/2018 Class II: PRODUCT Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theatre shoes and other miscellaneous reusable items used in...
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Company: Ion Beam Applications S.A. Date of Enforcement Report: 7/18/2018 Class II: PRODUCT Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Recall Number: Z-2424-2018 REASON Correction vector confirmation message...
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Yuki Gosei Kogyo Co., Ltd. Date:7/17/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide the...
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Company: Medtronic Inc. Date of Enforcement Report: 7/11/2018 Class II: PRODUCT Medtronic MiniMed Paradigm Vea Insulin Pump Product Catalog Number: MMT-554, MMT-754 Recall Number: Z-2377-2018 REASON Medtronic notified customers/users of MiniMed” Paradigm” Veo” insulin pump that the pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting...
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Company: GE Healthcare Finland Oy Date of Enforcement Report 7/11/2018 Class II: PRODUCT GE Healthcare CARESCAPE Monitor B650 Recall Number: Z-2340-2018 REASON When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not...
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Our newsletter in pdf form lists items added to the web site from mid-April 2017 through June 2018. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated ones. SoftwareCPR-June2018Newsletter
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Company: Baxter (Claris Injectables Ltd.) Date: 7/5/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies in data,...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis zeego, Material no. 10280959 Recall Number: Z-2314-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis zee MP, Material no. 10094139,, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2313-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class II: PRODUCT Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2311-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/4/2018 Class II: PRODUCT Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2312-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/4/2018 Class II: PRODUCT Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2310-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although...
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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 7/4/2018 Class lI: PRODUCT Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures. Recall Number: Z-2308-2018 REASON After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray...
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