Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging. Recall Number Z-0254-2016 REASON When performing head or neck scans, the currently displayed...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The Transmit/Receive Body Imaging...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device. Recall Number Z-0256-2016 REASON When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The...Read More

Company: Innokas Medical Oy.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans Recall Number Z-0264-2016 REASON Monitor may shut down unintentionally without restarting. RECALLING FIRM/MANUFACTURER Innokas Medical Oy. Kempele, FI on 10/22/2015. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 756 DISTRIBUTION Nationwide...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device. Recall Number Z-0258-2016 REASON When performing head or neck scans, the currently displayed SAR values could be lower...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device. Recall Number Z-0259-2016 REASON When performing head or neck scans, the currently displayed SAR...Read More

Company: GE Healthcare.Date of Enforcement Report 11/18/2015 Class lI: PRODUCT GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of...Read More

Company: Hamilton.Medical Date of Enforcement Report 8/26/2015 Class l: PRODUCT The G5 ventilator provides breathing support for adult, children, infant and newborn patients. The device is intended for use in hospital and other health care facilities. It may be used for transport within a hospital or health care facility. REASON The ventilator may stop working,...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/11/2015 Class lI: PRODUCT Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A Recall Number Z-0204-2016 REASON 1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and...Read More

Company: Steris Corporation Date of Enforcement Report 11/11/2015 Class lI: PRODUCT AMSCO 400 and AMSCO C Small Steam Sterilizers Recall Number Z-0210-2016 REASON In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 11/11/2015 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. Intended for use in the in vitro quantitative measurement of a variety of analytes...Read More

Company: GE Healthcare.Date of Enforcement Report 11/11/2015 Class lI: PRODUCT The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system...Read More

Company: Brainlab AG Date of Enforcement Report 11/11/2015 Class lI: PRODUCT Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 11/11/2015 Class lI: PRODUCT HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the...Read More

Company: GE Healthcare.Date of Enforcement Report 11/11/2015 Class lI: PRODUCT The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this...Read More

Company: Otto Bock Healthcare GmbHG Date of Enforcement Report 11/11/2015 Class lI: PRODUCT iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66* Triton Smart Ankle. Recall Number Z-0209-2016 REASON Otto Bock Healthcare GmbH has identified a software issue where the foot can produce an undesired response (can move into dorsiflexion)...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT CIOS ALPHA; image intensified fluoroscopic x-ray system Recall Number Z-0118-20166 REASON patient procedure interruption due to a potential system failure RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 8/7/2015 Voluntary: Firm Initiated recall is ongoing VOLUME OF PRODUCT IN COMMERCE 44...Read More

Company: Perkin Elmer Life Sciences Inc. Date of Enforcement Report 11/4/2015 Class lI: PRODUCT Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.Recall Number Z-0166-2016 REASON It would be possible for an abnormal analytical test result value from an affected newborn...Read More

Company:Natus Neurology Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and...Read More

Company:Elekta Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT Monaco – Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-0181-2016 REASON Unintended update of Dose and MU and Incorrect Assignment of Bolus. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta, GA on 10/16/2015 Voluntary: Firm Initiated recall...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 11/4/2015 Class lI: PRODUCT ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.Recall Number Z-0182-2016 REASON Siemens will provide all customers a new version of system software (VA35E or VB10C...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 10/28/2015 Class lI: PRODUCT All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-101A Recall Number Z-0013-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-101A Recall Number Z-0013-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-301B Recall Number Z-0015-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-301C Recall Number Z-0016-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-302A Recall Number Z-0017-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Toshiba American Medical Systems Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT Toshiba Aquilion CT System TSX-303A Recall Number Z-0018-2016 REASON it was found that if two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc., Tustin, CA on 5/8/2015 Voluntary:...Read More

Company:Natus Neurology Inc.Date of Enforcement Report: 10/21/2015 Class lI: PRODUCT NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Recall Number Z-0020-2016 REASON software bug issues for...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT Syngo RT Oncologist, an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Recall Number Z-0021-2016 REASON software bug issues for...Read More

Company:Elekta, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-0112-2016 REASON Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.. RECALLING FIRM/MANUFACTURER...Read More

Company: Toshiba American Medical Systems Inc.Date of Enforcement Report 10/14/2015 Class lI: PRODUCT Celesteion PCA-9000A/2 PET/CT System Recall Number Z-0005-2016 REASON It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem. RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems Inc, Tustin,...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients. Recall Number Z-0107-2016 REASON Software and firmware bugs RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 8/18/2015 Voluntary: Firm Initiated recall is ongoing VOLUME OF PRODUCT...Read More

Company: GE Healthcare.Date of Enforcement Report 10/14/2015 Class lI: PRODUCT Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Recall...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 10/14/2015 Class lI: PRODUCT SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. Recall Number Z-0019-2016 REASON software bug issues for...Read More

Company: Biosense Webster, Inc.Date of Enforcement Report 10/7/2015 Class lI: PRODUCT SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. Recall Number Z-0003-2016 REASON Image disappeared from the cardiac ultrasound system when the...Read More

Company: Biosense Webster, Inc.Date of Enforcement Report 10/7/2015 Class lI: PRODUCT Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps. Recall Number Z-0002-2016 REASON Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/30/2015 Class lI: PRODUCT ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 9/30/2015 Class lI: PRODUCT MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST). Recall Number Z-2809-2015 REASON Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/23/2015 Class lI: PRODUCT ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: 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 Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional,...Read More

Company: Medtronic Inc. Cardiac Rhythm Disease Management Date of Enforcement Report 9/23/2015 Class lI: PRODUCT Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures. Recall Number Z-2777-2015 REASON Medtronic has identified an issue with a USB memory component contained within a subset of CryoConsoles. The issue can result in extended...Read More

Company: Terumo Cardiovascular Systems Corporation Date of Enforcement Report 9/16/2015 Class lI: PRODUCT CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. Recall Number Z-2742-2015 REASON Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and...Read More

Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 9/16/2015 Class lI: PRODUCT Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate....Read More

Company: Insulet Corporation Date of Enforcement Report: 9/10/2015 Class l: PRODUCT The OmnniPod Insulin Management System is an insulin pump used to deliver insulin to people with diabetes. The insulin pump ?Pod? is a small adhesive pump that sticks directly on the body. Insulin is delivered through a small port holding a tube that is...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 9/9/2015 Class lI: PRODUCT Syngo.plaza; picture archiving and communications system Product Usage: 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. Syngo.plaza also supports...Read More

Company: Transonic Systems Inc Date of Enforcement Report 9/9/2015 Class lI: PRODUCT Transonic Flow Probes. Product Usage: to measure flow intra-operatively Reacll number 2720-2729. REASON Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69. RECALLING FIRM/MANUFACTURER Transonic Systems Inc, ithaca, NY on 7/27/2015. Voluntary: Firm Initiated...Read More

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