Tag

recall

Software Recall

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...
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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...
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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...
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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...
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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,...
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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...
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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...
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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,...
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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...
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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....
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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...
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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...
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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...
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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...
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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,...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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....
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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...
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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...
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Company:Mako Surgical Corporation.Date of Enforcement Report 9/20/2017 ClasslI: PRODUCT Makoplasty Partial Knee Application (PKA) 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-3130-2017 REASON Software discrepancy of not showing...
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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....
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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...
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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...
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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...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 9/13/2017 Class lI: PRODUCT Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical...
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Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a...
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Company:Neusoft Medical Systems Co., Ltd.Date of Enforcement Report 9/6/2017 ClasslI: PRODUCT Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into...
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Company:Datascope Corp./MAQUET. Date of Enforcement Report 9/6/2017 Class II: PRODUCT Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. The devices addressed in this communication are the following St. Jude Medical pacemaker and CRT-P devices: Accent, Anthem, Accent MRI, Accent ST, Assurity, Allure...
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Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery. Recall Number Z-3049-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error...
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Company:Alcon Research, Ltd..Date of Enforcement Report 8/30/2017 ClasslI: PRODUCT ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery Recall Number Z-3050-2017 REASON Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that...
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Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...
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Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...
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Company:Boston Scientific Corporation.Date of Enforcement Report 8/23/2017 ClasslI: PRODUCT EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is...
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Company:Soft Computer Consultants, Inc.Date of Enforcement Report 8/9/2017 ClasslI: PRODUCT SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, Recall Number Z-2865-2017 REASON Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent...
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Company:Beckman Coulter Inc.. Date of Enforcement Report 8/2/2017 Class lII: PRODUCT Beckman Coulter PK7300(R) Automated Microplate System, Catalogue Numbers: N3209000 and N2007600y Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number B-0741-2017 REASON Beckman Coulter’s PK7300, associated with a defect or glitch with the dispensing monitoring board, was distributed.. RECALLING FIRM/MANUFACTURER Bedkman Coulter, Brea, CA...
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Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 Class lI: PRODUCT CS 100i Intra-Aortic Balloon Pump. Recall Number Z-2736-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a...
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Company:Maquet Datascope Corp – Cardiac Assist Division Date of Enforcement Report 8/2/2017 ClasslI: PRODUCT CS 300 Intra-Aortic Balloon Pump Recall Number Z-2738-2017 REASON The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient...
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Company:Draegar Medical Systems, Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Recall Number Z-2734-2017 REASON Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.. RECALLING FIRM/MANUFACTURER Draegar...
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Company:Medtronic Navigation Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Recall Number Z-2746-2017 REASON Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server...
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Company:AGFA Healthcare Corp. Date of Enforcement Report 7/26/2017 Class lI: PRODUCT Agfa Healthcare NX 3.0.8950 Imaging Processing Software Recall Number Z-2735-2017 REASON A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and...
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Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 7/12/2017 Class lI: PRODUCT Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 — Programmable diagnostic computer, Recall Number Z-2688-2017 REASON Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/...
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Company:CareFusion 303, Inc. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT Alaris PC Unit, Model 8015 Recall Number Z-2671-2017 REASON BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions. RECALLING...
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Company: CardioTek BV. Date of Enforcement Report 7/12/2017 Class lI: PRODUCT CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. Recall Number Z-2657-2017 REASON Software bug which allows parameters to be changed unintentionally...
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