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

The Global Unique Device Identification Database is a database administered by the FDA that will serve as a reference catalog for every device with an identifier. May 2018 will start implementation of the releasability logic and the review period. Public release of premarket submission and supplement numbers on AccessGUDID and OpenFDA will begin in June 2018.Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/4/2018 Class lI: PRODUCT ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL. Recall Number Z-1200-2018 REASON The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions...Read More

Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 4/4/2018 Class lI: PRODUCT Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Recall Number Z-1261-2018 REASON When the...Read More

Company:St. Jude Medical, Inc..Date of Enforcement Report 4/4/2018 Class lI: PRODUCT Proclaim DRG Implantable Pulse Generator, Model Number 3664 Recall Number Z-1170-2018 REASON The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report 4/4/2018 Class lI: PRODUCT Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130 Recall Number Z-1275-2018 REASON Software issue with Center Beam in Field functionality. Issue can result in incorrect...Read More

This newsletter in pdf form lists items added to the web site from mid-November 2017 through late-November 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....Read More

Company:Smiths Medical ASD Inc..Date of Enforcement Report 3/28/2018 Class lI: PRODUCT The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal,...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/21/2018 Class lI: PRODUCT ACUSON SC2000 Ultrasound System Product Usage: 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 Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides...Read More

Company:Medtronic Navigation, Inc.Date of Enforcement Report 3/14/2018 Class lI: PRODUCT O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4)...Read More

Company:Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 3/14/2018 Class lI: PRODUCT A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient...Read More

Company:Abbott Point Of Care Inc.Date of Enforcement Report 3/14/2018 Class lI: PRODUCT i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255) Recall Number Z-0946-2018 REASON Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 3/14/2018 Class lI: PRODUCT Philips Network Firewall (Cisco ASA 5506)Product Usage:The Cisco ASA 5506-X provides IPv4 and IPv6 Routing and Network Address Translation (NAT) capabilities. It also provides the following: Port Filtering Stateful Packet Inspection Default Protection Policies These default policies trust all outgoing traffic and...Read More

Based on our searches and posting of software related recalls there appears to be a significant decrease of recalls reported to FDA in 2017 compared to 2016. Yearly total software recalls to the best of our ability to identify were for the past year are listed below. For previous years, search our library or look...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 3/7/2018 Class lI: PRODUCT Intellivue iX Information Center Software – All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 3/7/2018 Class lI: PRODUCT digital x-ray detector ProGrade R1 – solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for...Read More

Company:ZOLL Medical Corporation Date of Enforcement Report 3/7/2018 Class lI: PRODUCT 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. Recall...Read More

Company:Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report 3/7/2018 Class lI: PRODUCT Intellivue iX Information Center Software – All PIIC iX Surveillance stations including: 866023 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. Recall Number Z-0829-2018 REASON While reviewing documentation for the next software release of the 2008T,...Read More

The International Medical Device Forum, which FDA participates in, released a draft for comment entitled, “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.“  This guidance document describes fundamental design and manufacturing requirements, referred to as “Essential Principles of Safety and Performance” that, when met, indicate a medical device is safe and...Read More

You can search the app stores for SoftwareCPR® to download on an iPhone or Android. The app provides key FDA regulations and Software Guidances for quick reference and is organized by section. Impress your friends by accessing the exact text of FDA documents wherever you go. We plan to add additional documents over time.Read More

A committee draft for vote of “IEC 62304 Ed 2: Health Software – Software life cycle processes” has been circulated for ballot. Edition 2 expands the scope of IEC 62304 to include health software that is not regulated as a medical device, and the title has been changed accordingly. This will be the last opportunity...Read More

Company:Zimmer Biomet, Inc. Date of Enforcement Report 2/28/2018 Class lI: PRODUCT ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons. Recall Number Z- 0637-2018 REASON Robot arm being sent to the wrong position-2018 RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc.Warsaw, IN on 5/1/2017....Read More

Company:Zimmer Biomet, Inc. Date of Enforcement Report 2/28/2018 Class lI: PRODUCT ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons. Recall Number Z- 0638-2018 REASON Robot arm being sent to the wrong position-2018 RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc.Warsaw, IN on 5/1/2017....Read More

Company:Oculus Optikgeraete GMBH Date of Enforcement Report 2/28/2018 Class lI: PRODUCT OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye Recall Number Z-0635-2018 REASON...Read More

Company: Roche Diagnostics CorporationDate of Enforcement Report 2/28/2018 Class lI: PRODUCT Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001 Recall Number Z-0675-2018 REASON A software failure may incorrectly set the system settings to “default” settings, creating a risk of incorrect results. RECALLING FIRM/MANUFACTURER Roche Diagnostics Corporation, Indianapolis, IN on 4/28/2017. Voluntary:...Read More

Company:Med Tec Inc Date of Enforcement Report 2/28/2018 Class lI: PRODUCT Protura Software which utilizes Elekta’s iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch.....Read More

The FDA published the guidance document “Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.” The guidance document is in Q&A format, and provides clarifications and recommendations to help stakeholders ensure that studies conducted in the U.S. or foreign countries comply with the new rule and revised regulations. FDA WebsiteRead More

Company:Roche Diabetes Care, Inc. Date of Enforcement Report 2/21/2018 Class lI: PRODUCT Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 Recall Number Z-0625-2018 REASON Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/21/2018 Class lI: PRODUCT Ingenuity TF PET/CT (model 882442) running software version 4.0.2This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission...Read More

FDA made public that the effective date for compliance with the final rule on “Human Subject Protection – Acceptance of Data from Clinical Investigations for Medical Devices.”  According to the announcement from FDA, the “update relates to the standards for accepting clinical data from clinical investigations conducted inside and outside the United States” with the stated...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Ingenuity CT computed tomography x-ray system Recall Number Z-0521-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Ingenuity Core 128 computed tomography x-ray system Recall Number Z-0520-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Syngo.plaza systems with SW VB20A, Model Number – 10863171, 10863172, 10863173Product Usage:Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning....Read More

Company:Spacelabs Healthcare Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, Recall Number Z-0532-2018 REASON Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. RECALLING FIRM/MANUFACTURER Spacelabs Healthcare Inc., Snoqualmie, WA on 1/17/2018. Voluntary: Firm...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Ingenuity Core computed tomography x-ray system Recall Number Z-0519-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:Philips Medical Systems (Cleveland) Inc Date of Enforcement Report 2/14/2018 Class lI: PRODUCT Philips Brilliance 64 computed tomography x-ray system Recall Number Z-0518-2018 REASON Numerous issues related to software Brilliance iCT 4.1.6 software version. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 10/6/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

Company:Roche Diagnostics CorporationDate of Enforcement Report 2/7/2018 Class lI: PRODUCT cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 – cobas e 411 analyzer (disk system) and 04775201001/04775201973 – cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 2/7/2018 Class lI: PRODUCT Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the...Read More

Company:Roche Diagnostics CorporationDate of Enforcement Report 2/7/2018 Class lI: PRODUCT Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 – Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 – Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 – Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative...Read More

Company:Edwards Lifesciences, LLCDate of Enforcement Report 27/2018 Class lI: PRODUCT Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards...Read More

Company:Carl Zeiss Metrology IncDate of Enforcement Report 2/7/2018 Class lI: PRODUCT Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal. Recall Number Z-0379-2018 REASON Due to a software error, it was observed that when the user closes the access door, the system will resume...Read More

Company:GE Medical Systems Information Technologies, Inc.Date of Enforcement Report 27/2018 Class lI: PRODUCT GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information Recall Number Z-0487-2018 REASON CARESCAPE Central Station (CSCS)...Read More

Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 1/31/2018 Class lI: PRODUCT Brilliance iCT – Model 728306 Computed Tomography X-ray systems Recall Number Z-0403-2018 REASON Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image...Read More

Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 1/31/2018 Class lI: PRODUCT Brilliance iCT SP – Model 728311 Brilliance iCT – Model 728306 Computed Tomography X-ray systems Recall Number Z-0402-2018 REASON Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 1/31/2018 Class lI: PRODUCT Syngo Imaging version V31 (model # 10014063) 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. It supports the physician in diagnosis and treatment planning. Recall...Read More

Company:Medtronic Inc., Cardiac Rhythm and Heart FailureDate of Enforcement Report 1/31/2018 Class lI: PRODUCT MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data...Read More

Company:Medtronic Inc., Cardiac Rhythm and Heart FailureDate of Enforcement Report 1/31/2018 Class lI: PRODUCT MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device Recall Number Z-0400-2018 REASON Patients monitored on two (2) or...Read More

The FDA published the guidance document “Refuse to Accept Policy for 510(k)s.” This supersedes the original, issued on August 4, 2015. This revision provides for additional requirements to better ensure substantive content, not just administrative elements that are checked in the initial 15 day refuse to accept initial review. Refuse to Accept Policy for 510(k)sRead More