Tag

softwareerror
Company: Elekta, Inc. Date of Enforcement Report: 2/8/2019 Class II: PRODUCT MOSAIQ Oncology Information System and Sequencer 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-0821-2019 REASON There...
Read More
Company: Medtronic, Inc. Date of Enforcement Report: 1/17/2019 Class I: PRODUCT Medtronic’s Dual Chamber Implantable Pulse Generators (IPGs) are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 2/1/2019 Class II PRODUCT GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of...
Read More
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 2/1/2019 Class II PRODUCT MEDTRONIC CARELINK 2090 programmer Recall Number: Z-0795-2019 REASON There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 2/6/2019 Class II PRODUCT Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0776-2019 REASON On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation...
Read More
Company: NEUSOFT MEDICAL SYSTEMS IMP & EX Date of Enforcement Report: 2/5/2019 Class II PRODUCT NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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...
Read More
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 2/1/2019 Class II: PRODUCT MEDTRONIC CARELINK 2090 programmer Recall Number: Z-0795-2019 REASON There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 2/6/2019 Class II: PRODUCT Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0776-2019 REASON On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 1/29/2019 Class II PRODUCT Atellica IM 1300 Analyzer; In-vitro diagnostic testing of clinical specimens; Siemens Material Number (SMN): 1066001 Product Usage: The Atellica Solution is a multi-component system for in-vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of...
Read More
Company: Varian Medical Systems, Inc. Date of Enforcement Report: 1/24/2019 Class II PRODUCT Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only 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 external beam irradiation with photon,...
Read More
Company: Stryker Sustainability Solutions Date of Enforcement Report: 1/23/2019 Class II PRODUCT BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Recall Number: Z-0766-2019 REASON Stryker s Sustainability Solutions division (SSS)...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 10/24/2018 Class II: PRODUCT Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. Recall Number: Z-0195-2019 REASON Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI on...
Read More
Company: Agfa Healthcare NV Date of Enforcement Report 10/17/2018 Class II: PRODUCT Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as PACS Recall Number: Z-0101-2019 REASON Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the...
Read More

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.