Company: Hitachi America, Ltd., Power Systems Division Date of Enforcement Report: 7/29/2015 Class lI: PRODUCT PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachis PROBEAT with DSSS is a medical 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....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2196-2015 REASON Philips has...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2198-2015 REASON Philips has identified...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2199-2015 REASON Philips has...Read More

Company:Viewray Incorporated Date of Enforcement Report: 7/22/2015 Class lI: PRODUCT Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-2085-2015 REASON ViewRay” received a report that the couch moved unexpectedly into the bore...Read More

Company:Elekta, Inc. Date of Enforcement Report: 7/22/2015 Class lI: PRODUCT MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-2063-2015 REASON A problem exists in...Read More

Company:Siemens Healthcare Diagnostics, IncDate of Enforcement Report: 7/15/2015 Class lI: PRODUCT Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. Recall Number Z-2054-2015 REASON there is the potential for two software issues to occur in Vista software versions 3.6.1 Issue #1 :Samples stop...Read More

The first amendment to IEC 62304 amendment has been published as Edition 1.1. You can purchase just the amendment, which notates what has changed, or a consolidated redline version. It is currently available from ANSI or IEC. AAMI will publish it in the near future, although it may be expensive to purchase from AAMI. This amendment mainly focuses...Read More

The National Electrical Manufacturers Association (NEMA) has published a guidance document on supply chain best practices for electrical equipment and medical imaging manufacturers to minimize the possibility that bugs, malware, viruses, or other exploits can be used to negatively impact product operation. The document is a representation of identified best practices that vendors can implement...Read More

Mahendra Chemicals..Product: pharmaceutical manufacturing facility Date: 7/13/2015 Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data. Your laboratory systems lacked access controls to prevent raw data from being deleted or altered. For example, a) There is no assurance that you maintain complete electronic raw data...Read More

Company:Siemens Healthcare Diagnostics, IncDate of Enforcement Report: 7/8/2015 Class lI: PRODUCT CentraLink” Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. Recall Number Z-1972-2015 REASON Siemens became aware that during...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular,...Read More

Company:Viewray Incorporated Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT Treatment Planning and Delivery System Software version 3.6. ViewRay” Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-1954-2015 REASON The firm discovered that the software was failing to determine new...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal...Read More

Company:Siemens Healthcare Diagnostics, IncDate of Enforcement Report: 7/8/2015 Class lI: PRODUCT The Rapidlab 1260 and Rapidlab 1265 systems are blood gas analyzers used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples. Recall Number Rapid Lab 1260: Z-1961-2015 Rapidlab 1265 Z-1962-2015 REASON D50 and D51 Diagnostic...Read More

Company:Varian Medical Systems IncDate of Enforcement Report: 7/8/2015 Class lI: PRODUCT The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy. Recall Number Z-1849-2015...Read More

The CWE can be a useful reference to use when performing medical device software risk management and security vulnerability analysis. The Common Weakness Enumeration Specification (CWE) provides a common language of discourse for discussing, finding and dealing with the causes of software security vulnerabilities as they are found in code, design, or system architecture. Each...Read More

In August 2014, the Australian Therapeutic Goods Authority (TGA) gave a presentation on its approach to software regulation of medical devices.  This is a short and very clear high level presentation that explains the TGA’s focus and use of relevant standards such as 62304 as well as its focus on safety and risk management. View...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 7/2/2015 Class l: PRODUCT A syringe pump is a small infusion pump that delivers fluids, such as nutrients and medications, into a patient?s body in controlled amounts. They are widely used in clinical settings such as hospitals, nursing homes, and in the home.. REASON An error in...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/1/2015 Class lI: PRODUCT Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro...Read More

Company: New Star Lasers, Inc. Date of Enforcement Report: June 27, 2015 Class II PRODUCT StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. Recall Number:...Read More

Company: Mortara Instrument, Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It...Read More

Company: Philips Ultrasound Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit. Recall Number Z-1811-2015 REASON CareFusion...Read More

Company: Boston Scientific Corporation Date of Enforcement Report 6/24/2015 Class lI: PRODUCT CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 – 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. Recall Number Z-1743-2015 REASON Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing Recall...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. Recall Number Z-1742-2015 REASON Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing.Recall Z-1728-2015 REASON Software anomaly...Read More

Company: Elekta Inc. Date of Enforcement Report 6/17/2015 Class lI: PRODUCT Leksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment. Recall Number Z-1719-2015 REASON Memory can become corrupted when creating a fused study via drag & drop in Leksell GammaPlan 10.2. RECALLING FIRM/MANUFACTURER Elekta Inc.,...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/10/2015 Class lI: PRODUCT Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Recall Number Z-1705-2015 REASON measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series...Read More

/docs/scpred/SoftwareCPR-NewsletterJune15.pdfRead More

FDA issued a final version of its Universal Device Identification rule in 2013 and this rule is posted in the softwarecpr.com library. FDA also created and updates a webpage devoted to implementation of this rule (which will take place over seven years with higher risk devices sooner and lower risk devices at the end).Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. Recall Number...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 10 Air. Computed Tomography X-ray systems 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-1654-2015 REASON The firm was informed that while raising the patient...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance iCT. Computed Tomography X-ray systems 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-1656-2015 REASON The firm was informed that while raising the patient couch on...Read More

Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 16 Power. Computed Tomography X-ray systems 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-1651-2015 REASON The firm was informed that while raising the patient...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. Recall Number...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 40. Computed Tomography X-ray systems 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-1650-2015 REASON The firm was informed that while raising the patient couch...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Ingenuity CT. Computed Tomography X-ray systems 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-1657-2015 REASON The firm was informed that while raising the patient couch on...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 6 Air. Computed Tomography X-ray systems 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-1655-2015 REASON The firm was informed that while raising the patient...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT 64. Computed Tomography X-ray systems 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-1649-2015 REASON The firm was informed that while raising the patient couch...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems 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-1648-2015 REASON The firm was informed that while raising the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical...Read More

Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area....Read More

Company: Elekta Inc. Date of Enforcement Report 6/3/2015 Class lI: PRODUCT Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-1712-2015 REASON Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. RECALLING FIRM/MANUFACTURER...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report: 6/3/2015 Class lI: PRODUCT Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a...Read More