Company:Zimmer Biomet, IncDate of Enforcement Report 12/6/2017 Class lI: PRODUCT Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Recall Number Z-0177-2018 REASON A design change was...Read More

Company:BRAINLAB AGDate of Enforcement Report 12/6/2017 Class lI: PRODUCT BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear...Read More

Company:Volcano Corp.Date of Enforcement Report 12/6/2017 Class lI: PRODUCT Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 12/6/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional...Read More

An excerpt of the Medical Device Innovations Section of the US Law PLAW-114Publ255 referred to as the “21st Century Cures Act” and published in December of 2016 is at the link provided. There are many important elements of this law, including how accessories are classified and what software functions are not outside the definition of...Read More

The FDA maintains a dedicated webpage to provide ongoing information on FDA’s digital health initiative.Read More

CompanySiemens Medical Solutions USA, IncDate of Enforcement Report 11/29/2017 Class lI: PRODUCT Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Recall Number Z-0168-2018 REASON Siemens is releasing a non-medical software application LTA...Read More

Company:3M Company – Health Care BusinessDate of Enforcement Report 11/29/2017 Class lI: PRODUCT 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) Recall Number Z-0114-2018 REASON During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 11/29/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8. Recall Number Z-0115-2018 REASON Potential for software to change the final tool orientation for the command position without command. RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc.Warsaw, IN on 4/8/2016. Voluntary firm initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 64 units DISTRIBUTION...Read More

Company:Spacelabs Healthcare, Ltd.Date of Enforcement Report 11/29/2017 Class l: PRODUCT Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide...Read More

Company:Zimmer Biomet, IncDate of Enforcement Report 11/22/2017 Class lI: PRODUCT ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Recall Number Z-0102-2018 REASON An undetected shift between the information displayed in the navigation software and the actual...Read More

Company:ICU Medical IncDate of Enforcement Report 11/22/2017 Class lI: PRODUCT Plum 360 Infusion System, List number 30010. Recall Number Z-0101-2018 REASON (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the “Paused” state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be...Read More

Company:Siemens Medical Solutions USA, Inc..Date of Enforcement Report 11/22/2017 Class lI: PRODUCT Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. Serial Number: 2141,...Read More

Company:Siemens Medical Solutions USA, Inc..Date of Enforcement Report 11/22/2017 Class lI: PRODUCT Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. Serial Number: 2136,...Read More

Want a free Android app as a quick reference to the regulations? Paul Felten of SoftwareCPR has developed a new app just for that purpose. You can find it by searching for “SoftwareCPR” in the Google Play store!  Google Play – SoftwareCPR appRead More

The FDA issued its first approval of a Digital Medicine, ABILIFY MYCITE®, a new innovative treatment option in mental health. Otsuka, with the help of Proteus Inc., developed a sensor as part of the pill that communicates externally to provide confirmation the pill was ingested, along with details about it. This is for serious mental...Read More

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

Company:Boston Scientific Corporation.Date of Enforcement Report 11/15/2017 Class lI: PRODUCT RESONATE EL ICD VR, Model D432, Sterile. Recall Number Z-0077-2018 REASON The devices have an incorrect firmware configuration. RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Saint Paul, MN. on 10/4/2017. Voluntary: Firm Initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 5 devices DISTRIBUTION The devices were...Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SF NAV Catheters Model Numbers – BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S Recall Number Z-0058-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters....Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S Recall Number Z-0055-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402...Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S) Recall Number Z-0056-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a...Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S Recall Number Z-0054-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402...Read More

Company:Biosense Webster, Inc.Date of Enforcement Report 11/8/2017 Class lI: PRODUCT HERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter Recall Number Z-0057-2018 REASON Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a “Map: magnetic...Read More

Company:Nucletron BV Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a 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-0050-2018 REASON Incorrect...Read More

Company:Beckman Coulter Inc.. Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation. Recall Number Z-0046-2018 REASON Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process,...Read More

Company:Edap Technomed Inc. Date of Enforcement Report 11/1/2017 Class lI: PRODUCT Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue Recall Number Z-0049-2018 REASON The US FDA has requested the optional energy treatment settings, “medium” and “low” (Software Protocols 02-Medium and 03-Low) be...Read More

The FDA release a final guidance, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on October 30, 2017. This supersedes “New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff” dated February 19, 1998. This guidance defines the process for De Novo submissions for devices with no...Read More

The FDA published a draft guidance, “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff,” on October 25, 2017. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for...Read More

The FDA issued a new Final guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” on October 25, 2017. The full guidance is at the link provided. This supersedes the 1997 guidance. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are 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-0015-2018 REASON During a bolus...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Ingenuity Core128 Xray Tomography, Computed These computed tomography x-ray systems are 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-0018-2018 REASON During a bolus tracking...Read More

FDA published a draft guidance “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff” dated 10/25/17. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for certain medical devices...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Brilliance iCT Xray Tomography, Computed These computed tomography x-ray systems are 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-0019-2018 REASON During a bolus tracking...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Brilliance iCT SP Xray Tomography, Computed These computed tomography x-ray systems are 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-0020-2018 REASON During a bolus...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are 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-0017-2018 REASON During a bolus tracking...Read More

Company:oshiba American Medical Systems Inc Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are 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-0016-2018 REASON During a bolus tracking...Read More

Supersedes 1997 guidance. FDA issued a new Final guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” dated Oct. 25, 2017. TThe full guidance is at the link provided. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes specifically. Deciding When...Read More

Company:Beckman Coulter Inc.. Date of Enforcement Report 10/25/2017 Class lI: PRODUCT Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012....Read More

The EU has proposed a new regulation on cybersecurity.  While this regulation is not specific to the health sector, health is mentioned as critical infrastructure in the proposal. The proposal would provide a revised mandate, objectives, and tasks for ENISA, the “EU Cybersecurity Agency.”  The new tasks include: Facilitating the establishment and take-up of European...Read More

SoftwareCPR now has a validation blog at the link provided. The latest entry as of 18-Oct-2017 contains some Retrospective Validation Tips provided by SoftwareCPR founder Alan Kusinitz. Earlier entries relate to Part 11, Agile methods, and Health IT. ValidationCPR BlogRead More

The link provided is to the full text of the current Bill S.1656 in the US Congress titled “Medical Device Cybersecurity Act of 2017.” Note that bills may not pass into legislation or may be heavily modified prior to becoming law. S.1656Read More

The firm's quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured - remediation requiredRead More

The U.S. Food and Drug Administration released guidance document, “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff,” dated September 29, 2017. The guidance lists and explains the process for requesting meetings with the FDA. It explains proper use of these meetings, including examples of appropriate...Read More

A blog post by Brian Pate of SoftwareCPR see the link provided and scroll down. HealthIT and Software as a Medical DeviceRead More

SoftwareCPR now has a validation blog at the link provided. ValidationCPR BlogRead More

Company: Toshiba American Medical Systems Date of Enforcement Report 9/20/2017 Class lI: PRODUCT Toshiba Medical Radrex – i Digital Radiography X-ray systemRadrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of...Read More

Company:Baxter Healthcare CorpDate of Enforcement Report 9/20/2017 ClasslI: PRODUCT Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 Recall Number Z-3133-2017 REASON The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette....Read More

Company:Mako Surgical Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. Recall Number Z-3131-2017 REASON Software discrepancy of not showing all...Read More

Company:Boston Scientific Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving...Read More