Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT ONCOR” Avant-garde Recall Number Z-1490-2017 REASON Software updates RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 2/14/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 80 systems DISTRIBUTION Nationwide Distribution ___________________________________Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT ONCOR” Expression ONCOR” Impression ONCOR” Impression plus Recall Number Z-1491-2017 REASON Software updates RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 2/14/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 80 systems DISTRIBUTION Nationwide Distribution ___________________________________Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT ARTISTE” MV System Recall Number Z-1488-2017 REASON Software updates RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 2/14/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 80 systems DISTRIBUTION Nationwide Distribution ___________________________________Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-1496-2017 REASON For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from...Read More

Company: Nidek IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. Recall Number Z-1520-2017 REASON Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered...Read More

Company: Stanley Security Solutions Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button. Recall Number Z-1499-2017...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of...Read More

Company: Smiths Medical ASD, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15, Recall Number Z-1439-2017 REASON I20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data. Recall Number Z-1457-2017 REASON In some instances, the system will lock tabs within a study, even when a second user does not have the study...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT BrightView Xdesigned for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare Recall Number Z-1470-2017 REASON The software produced a number of ”do not route” exceptions, which may result in potential patient injury or delay in diagnosis or treatment.....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/22/2017 Class lI: PRODUCT 882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/15/2017 Class lI: PRODUCT Merge Cardio software using EchoIMS Recall Number Z-1415-2017 REASON A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/15/2017 Class lI: PRODUCT Merge Cardio software Recall Number Z-1403-2017 REASON When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 4/4/2016....Read More

Company:Physio-Control, Inc. Date of Enforcement Report 3/15/2017 Class l PRODUCT The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. Recall Number Z-1257-2017 REASON The firm has received complaints that the LIFEPAK 1000 Defibrillator is...Read More

Company: Mckesson Medical Imaging Date of Enforcement Report 3/8/2017 Class lI: PRODUCT McKesson Radiology 12.2 – Picture Archive Communication System (PACS). Recall Number Z-1245-2017 REASON Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a...Read More

Company:Medtronic Neuromodulation Date of Enforcement Report 3/8/2017 Class l PRODUCT Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Recall Number Z-0788-2017 REASON Medtronic is following...Read More

Company: Tosoh Smd Inc Date of Enforcement Report 3/1/2017 Class lI: PRODUCT Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. Recall Number Z-1245-2017...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 3/1/2017 Class lI: PRODUCT Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/1/2017 Class lI: PRODUCT Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI. Recall Number Z-1246-2017 REASON Eye Station images were not importing properly and were imported under...Read More

Company: Denttio, Inc.Product: digital x-ray image receptors and intraoral microscope/cameras Date:2/23/2017 Failure to perform device software validation and risk analysis as required by 21 CFR 820.30(g). For example, you do not have records to demonstrate that your Imaging Software used with the Tio-H Digital X-Ray Sensor has been validated. You do not have records to...Read More

Company: BioMerieux SA Date of Enforcement Report 2/22/2017 Class lI: PRODUCT VIDAS 3 software v. 1.1.4 Recall Number Z-1200-2017 REASON During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4. available in the field. RECALLING FIRM/MANUFACTURER...Read More

Company: Physio-Control, Inc. Date of Enforcement Report 2/15/2017 Class lI: PRODUCT LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. Recall Number Z-1144-2017 REASON The End-Tidal CO2 (EtCO2) reading can intermittently show a value...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/152017 Class lI: PRODUCT Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-1180-2017 REASON The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/152017 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-1176-2017 REASON Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland,...Read More

Company: Physio-Control, Inc. Date of Enforcement Report 2/15/2017 Class lI: PRODUCT LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of...Read More

Company: Boston Scientific Corporation Date of Enforcement Report 2/152017 Class lI: PRODUCT Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Station Recall Number Z-1178-2017 REASON There is a potential for radio frequency...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/15/2017 Class lI: PRODUCT Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Station Recall Number Z-1142-2017 REASON Merge received reports of Merge Eye Station...Read More

Company: Mevion Medical Systems, Inc.. Date of Enforcement Report 2/8/2017 Class lI: PRODUCT MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy Recall Number Z-1122-2017 REASON An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened RECALLING FIRM/MANUFACTURER Mevion Medical Systems, Inc., Littleton, MA on...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/8/2017 Class lI: PRODUCT Syngo.plaza, picture archiving and communications system. Recall Number Z-1116-2017 REASON Software update for improvements and to resolve several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 1/11/2017 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/8/2017 Class lI: PRODUCT Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation....Read More

Company: Roche Diabetes Care, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Accu-Chek Connect Diabetes Management App Recall Number Z-1099-2017 REASON iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using...Read More

Company: Soft Computer Consultants, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure Recall Number Z-1091-2017 REASON There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Cobas b 123 POC systemThe cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives...Read More

Company: Soft Computer Consultants, Inc. Date of Enforcement Report 2/1/2017 Class lI: PRODUCT Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.. Recall Number Z-1098-2017 REASON Software error. Potential for...Read More

Company: DICOM GRID INC Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images. Recall Number Z-1045-2017 REASON A software error caused the window/level to become the same in one series regardless if the image had...Read More

Company: Carefusion Date of Enforcement Report 1/25/2017 Class I: PRODUCT Product Description: Alaris Syringe Pump Module (Large Volume Pump), Model No. 8100 and AIL sensor kits Recall number Z-0950-2017 REASON CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of...Read More

Company: Blood Bank Computer Systems, IncDate of Enforcement Report 1/25/2017 Class lI: PRODUCT Blood Bank Control System (BBCS) Primary Application, V 5.4.3, 5.5 is intended to address all phases of donor and transfusion services. The software is also capable of operating with or without ABO QuickPass (BK14130) to allow donors to complete Computer Assisted Self...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 1/25/2017 Class lII: PRODUCT AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process....Read More

Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Fresenius 2008T Series Hemodialysis System Recall Number Z-1026-2017 through Z-1029-2017 REASON When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled...Read More

Company:Elekta, Inc.Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-1044-2017 REASON Incorrect dose after editing beam number an wedge angle. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta, GA, on 1/10/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...Read More

Company: Carestream Health Inc Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body Recall Number Z-1052-2017 REASON Software error; Carestream Health Inc, received a complaint stating that when a user...Read More

Company: The Binding Site Group, Ltd. Date of Enforcement Report 1/25/2017 Class lI: PRODUCT Digital RID Plate Reader and Software Product Code: AD400 Recall Number Z-1055-2017 REASON If a control ring is marked after reading, the software will not flag results that are out of the specified QC range. RECALLING FIRM/MANUFACTURER The Binding Site Group,...Read More

Company: Toshiba American Medical Systems Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Kalare DREX-KL80, Model No. KXO-80XD Diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations Recall Number Z-1021-2017 REASON It has been found that the generator of the system could possibly terminate the exposure prematurely during an...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer. Recall Number Z-0987-2017 REASON Cross profile for Varian 60 degree wedge shows “horns.”...Read More

Company:Varian Medical Systems, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan...Read More