Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Merge HEMO software Recall Number Z-2341-2016 REASON The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7 RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. Hartland, WI on 7/2/2012 Voluntary:...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or...Read More

Company: B-K Medical A/S. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT BK Medical ApS Ultrasound System Scanner bk2300 – Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...Read More

The European Union has published a Directive concerning measures for a high common level of security of network and information systems across the Union.  The directive does not impose any new requirements on manufacturers that are not operators of essential services or digital services. Instead, it relies on existing rules on product liability. EU Network...Read More

Company: Elekta, Inc. Date of Enforcement Report 8/3/2016 Class lI: PRODUCT MOSAIQ Oncology Information System Recall Number Z-2293-2016 REASON It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order. RECALLING FIRM/MANUFACTURER Elekta, Inc., Atlanta,...Read More

Company: The Metrix Company Date of Enforcement Report 8/3/2016 Class lI: PRODUCT AUTOCOMP6 High Speed Compounder Recall Number Z-2259-2016 REASON An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined...Read More

Company: The Metrix Company Date of Enforcement Report 8/3/2016 Class lI: PRODUCT AUTOCOMP6 XP High Speed Compounder REF 58810 Recall Number Z-2258-2016 REASON An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device,...Read More

Company: The Metrix Company Date of Enforcement Report 8/3/2016 Class lI: PRODUCT AUTOCOMP6 XPS High Speed Compounder REF 58810 Recall Number Z-2257-2016 REASON An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device,...Read More

Company: Ge Healthcare ItDate of Enforcement Report 8/3/2016 Class lI: PRODUCT Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing...Read More

Adamson Analytical Laboratories, Inc.Product: finished pharmaceuticals Date: 8/2/2016 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, 21 CFR parts 210 and 211, and significant deviations from CGMP for active pharmaceutical ingredients (API). Your firm failed to exercise appropriate controls over computer or related systems to assure that...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM512648.pdfRead More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report 7/27/2016 Class lI: PRODUCT RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 — Radiation Therapy Treatment Planning System — designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions. Recall Number Z-2206-2016 REASON...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images Recall Number Z-2245-2016 REASON Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors....Read More

Company: Bayer Healthcare Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to...Read More

Company: Toshiba America Medical Systems Inc. Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System Recall Number Z-2188-2016 REASON During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found...Read More

Company: WalkMed Infusion LLC Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000)The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. Recall Number Z-2219-2016 REASON WalkMed Infusion, LLC Announces a...Read More

Company: Carestream Health Inc Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 — Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body Recall Number Z-2217-2016 REASON A software issue related to the generic volume measurement...Read More

http://www.fda.gov/MedicalDevices/DigitalHealth/ucm512245.htmRead More

Company: Merge Healthcare, Inc. Date of Enforcement Report 7/20/2016 Class lI: PRODUCT Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. Recall Number Z-2159-2016 REASON Potential data loss occurs as a result of product archiving not working properly. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc, Hartland, WI on 1/31/16 Voluntary: Firm Initiated...Read More

Company: Varian Medical Systems Date of Enforcement Report 7/20/2016 Class lI: PRODUCT Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian’s TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery....Read More

Company: Varian Medical Systems Date of Enforcement Report 7/20/2016 Class lI: PRODUCT Optical Surface Monitoring System{Align RT Plus} This is used on Varian’s TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.. Recall...Read More

Company: Novarad Corporation Date of Enforcement Report 7/20/2016 Class lI: PRODUCT NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS). Recall Number Z-2151-2016 REASON Potential for images to be flipped while streaming, which could incorrectly display image orientation markers. RECALLING FIRM/MANUFACTURER Novarad Corporation , American...Read More

Company: ZYTO Technologies Inc. Date of Enforcement Report 7/13/2016 Class lI: PRODUCT The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline). Recall...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 7/13/2016 Class lI: PRODUCT VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through...Read More

Company: ZYTO Technologies Inc. Date of Enforcement Report 7/13/2016 Class lI: PRODUCT The ZYTO Tower is the input device to program the software with various virtual items. Recall Number Z-2120-2016 REASON ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance....Read More

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure .Date of Enforcement Report 7/13/2016 Class lI: PRODUCT Medtronic, MyCareLink” Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician. Recall Number Z-2125-2016...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/62016 Class lI: PRODUCT Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes…...Read More

Company: CareFusion 303 Inc.Date of Enforcement Report 7/6/2016 Class lI: PRODUCT Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System. Recall Number Z-2064-2016 REASON A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/62016 Class lI: PRODUCT Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/62016 Class lI: PRODUCT Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-2117-2016 REASON Philips Healthcare received...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 7/6/2016 Class lI: PRODUCT Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers – 10863171, 10863172, 10863173, Recall Number Z-2088-2016 REASON Software error in previous software versions in which two references for the same image may exist in the database. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 7/6/2016 Class lI: PRODUCT SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets., Recall Number Z-2107-2016 REASON Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior:...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2024-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2006-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.. Recall Number Z-2026-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2037-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 64 – 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2013-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2027-2016 REASON Siemens Medical...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2008-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2029-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2017-2016 REASON...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 40 – 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2007-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2031-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2018-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2010-2016 REASON Siemens...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2032-2016 REASON Siemens Medical Solutions,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 6/29/2016 Class lI: PRODUCT BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Recall Number Z-2023-2016 REASON Siemens Medical...Read More