Company: Ortho-Clinical Diagnostics Date of Enforcement Report 9/9/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD — Ortho Clinical Diagnostics Inc. The VITROS 5,1 FS Chemistry System with enGEN(TM)...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 9/2/2015 Class lI: PRODUCT Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians. Recall Number Z-2383-2015 REASON The system is designed to emit a...Read More

Company:Carestream Health Inc.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. Recall Number Z-2449-2015 REASON Carestream became aware of an issue with...Read More

Company:GE Healthcare.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include...Read More

Company:Brainlab AGDate of Enforcement Report: 9/2/2015 Class lI: PRODUCT ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Recall Number Z-2440-2015 REASON ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect...Read More

Company:Nidek Inc.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement...Read More

Company:GE Healthcare.Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations,...Read More

Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report: 8/26/2015 Class lI: PRODUCT RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy. Recall Number Z-2457-2015 REASON Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used....Read More

Company:Medtronic MiniMed Inc..Date of Enforcement Report: 9/2/2015 Class lI: PRODUCT Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management. Recall Number Z-2442-2015 REASON Medtronic MiniMed is recalling...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 8/26/2015 Class lI: PRODUCT Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Recall Number Z-2404-2015 REASON in case a system error occurs and the system enters the “Bypass Fluoro”...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 8/26/2015 Class l: PRODUCT Alaris Syringe Pump, Model No. 8110. Delivers fluids. Recall Number Z-2362-2015 REASON Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump...Read More

Company: Covidien LP Date of Enforcement Report 8/262015 Class l: PRODUCT Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). Recall Number Z-2329-2015 REASON Reports...Read More

Company: BIOTRONIK Inc.. Date of Enforcement Report 8/19/2015 Class lI: PRODUCT PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle. Recall Number Z-2376-2015 REASON...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 8/12/2015 Class lI: PRODUCT Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation....Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 8/52015 Class lI: PRODUCT ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small...Read More

Company: Hamilton Medical. Date of Enforcement Report 8/5/2015 Class lI: PRODUCT Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients. Recall Number Z-2057-2015 REASON Customer reports that the ventilator display can freeze. Ventilation continues but...Read More

Company: Medtronic MiniMed Inc.. Date of Enforcement Report 8/5/2015 Class lI: PRODUCT MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712. Recall Number Z-2260-2015 REASON Medtronic MiniMed is recalling the MiniMed 620G and...Read More

Company: McKesson Technologies, Inc. Date of Enforcement Report 8/5/2015 Class lI: PRODUCT Paragon Laboratory Management. Recall Number Z-2263-2015 REASON For Paragon Laboratory Management 12.1 and 12.1.1 releases, if used with Microsoft SQL Server 2012, the Final Cumulative Report may incorrectly display the data. RECALLING FIRM/MANUFACTURER McKesson Technologies, Inc., Charlotte, NC on 6/15/2014. Voluntary: Firm Initiated...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 8/52015 Class lI: PRODUCT ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2195-2015 REASON Philips has...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2196-2015 REASON Philips has...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2198-2015 REASON Philips has identified...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2199-2015 REASON Philips has...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2197-2015 REASON Philips has identified...Read More

Company:Volcano Corporation Date of Enforcement Report: 7/29/2015 Class lI: PRODUCT 1) Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2193-2015 REASON Philips has...Read More

Company: Hitachi America, Ltd., Power Systems Division Date of Enforcement Report: 7/29/2015 Class lI: PRODUCT PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachis PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. Recall Number Z-2200-2015 REASON Philips, Pinnacle Radiation Treatment Planning System version 9 0, 9 2 9 4, 9 6 is being recalled because the dose may...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 7/29/2015 Class lI: PRODUCT GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Recall Number Z-2194-2015 REASON Philips has identified four...Read More

Company:Viewray Incorporated Date of Enforcement Report: 7/22/2015 Class lI: PRODUCT Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-2085-2015 REASON ViewRay” received a report that the couch moved unexpectedly into the bore...Read More

Company:Elekta, Inc. Date of Enforcement Report: 7/22/2015 Class lI: PRODUCT MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Recall Number Z-2063-2015 REASON A problem exists in...Read More

Company:Siemens Healthcare Diagnostics, IncDate of Enforcement Report: 7/15/2015 Class lI: PRODUCT Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. Recall Number Z-2054-2015 REASON there is the potential for two software issues to occur in Vista software versions 3.6.1 Issue #1 :Samples stop...Read More

Company:Siemens Healthcare Diagnostics, IncDate of Enforcement Report: 7/8/2015 Class lI: PRODUCT CentraLink” Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular,...Read More

Company:Varian Medical Systems IncDate of Enforcement Report: 7/8/2015 Class lI: PRODUCT The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy. Recall Number Z-1849-2015...Read More

Company:Siemens Healthcare Diagnostics, IncDate of Enforcement Report: 7/8/2015 Class lI: PRODUCT The Rapidlab 1260 and Rapidlab 1265 systems are blood gas analyzers used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples. Recall Number Rapid Lab 1260: Z-1961-2015 Rapidlab 1265 Z-1962-2015 REASON D50 and D51 Diagnostic...Read More

Company:Viewray Incorporated Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT Treatment Planning and Delivery System Software version 3.6. ViewRay” Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. Recall Number Z-1954-2015 REASON The firm discovered that the software was failing to determine new...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: 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...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/8/2015 Class lI: PRODUCT SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging 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. Recall Number Z-1972-2015 REASON Siemens became aware that during...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 7/2/2015 Class l: PRODUCT A syringe pump is a small infusion pump that delivers fluids, such as nutrients and medications, into a patient?s body in controlled amounts. They are widely used in clinical settings such as hospitals, nursing homes, and in the home.. REASON An error in...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 7/1/2015 Class lI: PRODUCT Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro...Read More

Company: New Star Lasers, Inc. Date of Enforcement Report: June 27, 2015 Class II PRODUCT StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. Recall Number:...Read More

Company: Mortara Instrument, Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit. Recall Number Z-1811-2015 REASON CareFusion...Read More

Company: Philips Ultrasound Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis...Read More

Company: Boston Scientific Corporation Date of Enforcement Report 6/24/2015 Class lI: PRODUCT CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 – 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. Recall Number Z-1742-2015 REASON Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected...Read More

Company: Elekta Inc. Date of Enforcement Report 6/17/2015 Class lI: PRODUCT Leksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment. Recall Number Z-1719-2015 REASON Memory can become corrupted when creating a fused study via drag & drop in Leksell GammaPlan 10.2. RECALLING FIRM/MANUFACTURER Elekta Inc.,...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing.Recall Z-1728-2015 REASON Software anomaly...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 6/17/2015 Class lI: PRODUCT Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing Recall...Read More