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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT Biograph Horizon – PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. Recall Number: Z-15972018 REASON Error introduced into PET images acquired and reconstructed with VJ20A software. Array values are indexed improperly when the norm file is created during QC. During data...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1459-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based...Read More

Company:Radiometer Medical ApSDate of Enforcement Report 5/9/2018 Class lI: PRODUCT AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1457-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1451-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior)...Read More

Company:Hitachi Ltd., Medical System Operations Group Date of Enforcement Report 5/9/2018 Class lI: PRODUCT MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall Number: Z-1585-2018 REASON Due to a system controller software anomaly, the...Read More

Company:PerkinElmer Life and Analytical Sciences, Wallac, OYDate of Enforcement Report 5/9/2018 Class lI: PRODUCT Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs....Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 5/9/2018 Class lI: PRODUCT Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1453-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1448-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1452-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1447-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior)...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1446-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1449-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior)...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1450-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Roche Diagnostics CorporationDate of Enforcement Report 5/9/2018 Class lI: PRODUCT cobas b 221Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1448-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Roche Diagnostics CorporationDate of Enforcement Report 5/9/2018 Class lI: PRODUCT cobas b 221Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1445-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Roche Diagnostics CorporationDate of Enforcement Report 5/9/2018 Class lI: PRODUCT cobas b 221Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1454-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1458-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1456-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/9/2018 Class lI: PRODUCT SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Recall Number: Z-1455-2018 REASON To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a....Read More

FDA issued a draft guidance dated April 27, 2018 titled: “Multiple Function Device Products: Policy and Considerations.”  This guidance expands on when and how FDA intends to assess the impact of other functions that are not the subject of a premarket review on the safety and effectiveness of a device function subject to FDA review.  It...Read More

Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 4/25/2018 Class lI: PRODUCT ngenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number: Z-1398-2018 REASON Control Console software has been updated to reduce the risk for collision...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1399-2018 REASON Control Console software has been updated to reduce the risk for collision...Read More

Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, Date of Enforcement Report 4/25/2018 Class lI: PRODUCT GE Healthcare:a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Impression plus, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1401-2018 REASON Control Console software has been updated to reduce the risk for...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT ONCOR Impression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1400-2018 REASON Control Console software has been updated to reduce the risk for collision...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT PRIMUS HI, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer Recall Number: Z-1402-2018 REASON Control Console software has been updated to reduce the risk for collision...Read More

Company:GE Medical Systems Ultrasound & Primary Care Diagnostics, Date of Enforcement Report 4/25/2018 Class lI: PRODUCT 1. GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 4/25/2018 Class lI: PRODUCT MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number: Z-1397-2018 REASON Control Console software has been updated to reduce the...Read More

Company:Lifeline Systems Company.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. Recall Number Z-1316-2018 REASON A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable. RECALLING FIRM/MANUFACTURER Lifeline Systems Company, Framingham, MA on 11/13/2017. Voluntary: Firm Initiated recall...Read More

Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 4/18/2018 Class lI: PRODUCT Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis. Recall Number Z-1365-2018 REASON The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result...Read More

Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer Recall Number Z-1362-2018 REASON Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal...Read More

Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland. Recall Number Z-1341-2018 REASON The device may process...Read More

Company:Philips Electronics North America CorporationDate of Enforcement Report 4/18/2018 Class lI: PRODUCT IntelliVue X3 Patient Monitor.. Recall Number Z-1315-2018 REASON The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to...Read More

Company:Beckman Coulter Inc.Date of Enforcement Report 4/18/2018 Class lI: PRODUCT iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100. Recall Number Z-1366-2018 REASON iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria. RECALLING FIRM/MANUFACTURER Beckman...Read More

Ron Baerg, of Seminole, FL USA, is now a partner at Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®), a full service medical device compliance and premarket submissions consultancy. Ron has over twenty three years experience in medical device software development and management. His experience has been primarily focused on large, complex medical device systems...Read More

FDA issued a draft guidance for comment: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Contains Nonbinding Recommendations Draft – Not for Implementation Equivalence through Performance Criteria. The outline shows a Section 17 for software information. The outline can be viewed here.Read More

Company:Baxter Healthcare CorporationDate of Enforcement Report 4/11/2018 Class lI: PRODUCT Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system.Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. Recall Number Z-1280-2018 REASON Firm has received reports of device operators failing to adhere to...Read More

Company:GE HealthcareDate of Enforcement Report 4/11/2018 Class lI: PRODUCT GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or...Read More

Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 4/11/2018 Class lI: PRODUCT 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy. Recall Number Z-1278-2018 REASON...Read More