Company:Roche Diagnostics CorporationDate of Enforcement Report 4/192017 Class lI: PRODUCT Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Recall Number Z-1763-2017 REASON “Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when...Read More

Company:PerkinElmer Life and Analytical Sciences, Wallac, OYDate of Enforcement Report 4/192017 Class lI: PRODUCT Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Recall Number Z-1761-2017 REASON “Roche Diagnostics Corp. initiated a voluntary correction because a...Read More

Company:Roche Diagnostics CorporationDate of Enforcement Report 4/192017 Class lI: PRODUCT Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Recall Number Z-1764-2017 REASON “Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when...Read More

Company:Philips Electronics North America Corporation Date of Enforcement Report 4/12/2017 Class lI: PRODUCT Philips IntelliVue MX4O WLAN Patient Wearable MonitorProduct: 865352Exchange part (service numbers):453564615311 TELE PWM,802.lla/b/g,ECG only, US only453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US onlyProduct Usage:Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Recall...Read More

Company:Philips VisicuDate of Enforcement Report 4/12/2017 Class lI: PRODUCT eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient...Read More

Company:Respironics California Inc, Inc. Date of Enforcement Report 4/5/2017 Class lI: PRODUCT Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 4/5/2017 Class lI: PRODUCT iConnect Enterprise Archive software Recall Number Z-1700-2017 REASON The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 4/5/2017 Class lI: PRODUCT iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data Recall Number Z-1697-2017 REASON The study is archived but cannot be opened in iConnect Access and cannot...Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 4/5/2017 Class lI: PRODUCT Syngo.via Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Recall Number Z-1689-2017 REASON Software changes now available to address several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions...Read More

The EU MDR of April, 5, 2017 is at the link below.  Clause (19) states: “It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a...Read More

Company: Hospira, Inc. Date of Enforcement Report 4/5/2017 Class lI: PRODUCT Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions Recall Number Z-1682-2017 REASON Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy...Read More

Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 4/5/2017 Class lI: PRODUCT Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Recall Number Z-1688-2017 REASON Software changes now available to address several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report 4/5/2017 Class lI: PRODUCT SynchroMed II implantable drug infusion pump, Model 8637-40, Recall Number Z-1694-2017 REASON Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from...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 Syngo.plaza, Picture Archiving and Communications System (PACS)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. Recall Number Z-1533-2017 REASON...Read More

Company: Siemens Healthcare Diagnostics, IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Collects and maintains patient...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare. Recall Number Z-1498-2017 REASON System locks up which may result in potential patient injury or delay in diagnosis or treatment. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on...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: 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: Zimmer Biomet, Inc.Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery. Recall Number Z-1495-2017 REASON Digital templates were created with the incorrect files. RECALLING FIRM/MANUFACTURER Zimmer Biomet, Inc., Warsaw, IN on 2/14/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME...Read More

Company: Hitachi Medical Systems America Inc Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Hitachi Oasis MRI System Recall Number Z-1540-2017 REASON Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. RECALLING FIRM/MANUFACTURER Hitachi Medical Systems America Inc., Twinsburg, OH on 4/16/2015. Voluntary: Firm Initiated recall...Read More

Company: Haag-Streit USA IncDate of Enforcement Report 3/29/2017 Class lI: PRODUCT EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). Recall Number Z-1500-2017 REASON There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow. RECALLING FIRM/MANUFACTURER Haag-Streit USA Inc., Mason...Read More

Company: Hitachi Medical Systems America Inc Date of Enforcement Report 3/29/2017 Class lI: PRODUCT Hitachi Oasis MRI System Recall Number Z-1542-2017 REASON Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. RECALLING FIRM/MANUFACTURER Hitachi Medical Systems America Inc., Twinsburg, OH on 4/16/2015. Voluntary: Firm Initiated recall...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: 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: 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.. Recall Number Z-1486-2017 REASON Cardio study list does not show STAT studies without refreshing. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling. VOLUME OF PRODUCT IN COMMERCE 217 sites potentially have the affected...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: 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

FDA seeks manufacturers to provide onsite learning opportunities for FDA staff. In the areas of Digital Health/Software FDA is interested in 4 topics: Cybersecurity, Software Development, Total product life-cycle development processes and methodologies, and Software testing. The link provided is the main FDA webpage on this program and has a link to the full list...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: 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: 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: 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 3/22/2017 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

FDA issued a draft list of Class II Medical Devices exemptions from the 510(k) premarket notification requirements to comply with the 21st Century Cures Act. Note that 884.1630 is NOT exempt if it contains software for image analysis or smartphone use. Other software-related sections of note are 86.2570 and 882.1470.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: 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: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

The presention material for the FDA Webinar – Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance – February 23, 2017 is at the link provided. FDA Presentation on Benefit-Risk IDE DevicesRead 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 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: 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