Company: Radiometer America Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or...Read More

Company: Varian Medical SystemsDate of Enforcement Report 10/3/2018 Class lI: PRODUCT TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated....Read More

FDA Center for Biologics provides manufacturers with technical assistance. For email and phone contact information, and other information about this service, click the link.Read More

Company: Varian Medical SystemsDate of Enforcement Report 10/10/2018 Class lI: PRODUCT VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Recall Number: Z-0005-2019 REASON Reports have been received of...Read More

October is National Cybersecurity Month; for more information from FDA click the link.Read More

Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.Read More

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...Read More

Company: Boston Scientific Corporation Date of Enforcement Report 10/3/2018 Class II: PRODUCT Model 3300 LATITUDE(TM) Programming System 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 (PG)....Read More

Company: Medtronic Navigation, Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 – 3.2, Product #: 9735542 Recall Number: Z-3251-2018 REASON Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the...Read More

Company: Tosoh Bioscience Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT G8 Automated HPLC Analyzer – 723G8 Product Usage – In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in...Read More

Company: Swissray Date of Enforcement Report 10/3/2018 Class lI: PRODUCT ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging. Serial Numbers within U.S.A commerce – 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005,...Read More

Philadelphia, PA: The MedTech Conference features senior level politicians and executives and a wide array of educational programming. For more information, click the link provided.  Read More

Company: Stryker GmbH. Date of Enforcement Report 10/3/2018 Class II: PRODUCT Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002 Recall Number: Z-3240-2018 REASON When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2,...Read More

UL 5500 – Safety for Remote Software Updates has been adopted as a U.S. National Standard. It covers the remote updating of software via the manufacturer’s recommended process. It is limited to software elements having an influence on safety and on compliance with the particular end product safety standard. It is not specific for medical...Read More

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...Read More

Company:Fresenius Medical Care Renal Therapies Group, LLC.Date of Enforcement Report 9/26/2018 Class lI: PRODUCT 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy. Recall Number: Z-3195-2018 REASON In the hemodialysis machine during the cleaning/disinfection program, when there...Read More

Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 9/26/2018 Class lI: 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 program, when...Read More

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...Read More

Company:Mako Surgical CorporationDate 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 where...Read More

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...Read More

Company:Mobius Imaging, LLC..Date of Enforcement Report 9/26/2018 Class lI: 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 completed.....Read More

For a quick and easy way to find US regulations, including those related to FDA, click the link provided.  Read More

To search FDA MDRs, click the link provided.  Read More

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....Read More

Company:Hitachi Healthcare Americas Corp Informatics Division.Date of Enforcement Report 9/12/2018 Class lI: 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. RECALLING FIRM/MANUFACTURER...Read More

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...Read More

Company:McKesson Israel Ltd..Date of Enforcement Report 9/12/2018 Class lI: 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 data management,...Read More

Company:Canon Medical System, USA, INC.Date of Enforcement Report 9/12/2018 Class lI: 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 (FPD),...Read More

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...Read More

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...Read More

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....Read More

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...Read More

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...Read More

Pharmaceutical Laboratories and Consultants, Inc. Product: testing laboratory 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...Read More

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...Read More

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...Read More

Company:LIEBEL-FLARSHEIM COMPANY LLCDate of Enforcement Report 8/29/2018 Class lI: 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. The difference...Read More

Company:Ortho Kinematics, IncDate of Enforcement Report 8/29/2018 Class lI: 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 the Vertebral...Read More

Company:LIEBEL-FLARSHEIM COMPANY LLCDate of Enforcement Report 8/29/2018 Class lI: 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 invasive urology/...Read More

Company:Tosoh Bioscience Inc Date of Enforcement Report 8/22/2018 Class lI: PRODUCT NG8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This...Read More

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...Read More

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....Read More

Company:Spacelabs Healthcare, Ltd.Date of Enforcement Report 8/22/2018 Class lI: 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 Arkon Anesthesia...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More