Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virt...
Reason: Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical ...
Z-2235-2014August 20, 2014Boulder, CO
Philips Medical Systems (Cleveland) Inc
Class IITerminated
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications serve...
Reason: The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan w...
Z-2237-2014August 20, 2014Cleveland, OH
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical...
Reason: Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect p...
Z-2140-2014August 13, 2014Rochester, NY
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic...
Reason: Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect p...
Z-2139-2014August 13, 2014Rochester, NY
PerkinElmer Health Sciences, Inc.
Class IITerminated
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retr...
Reason: Potential for demographic information and test result to be mismatch.
Z-2166-2014August 13, 2014Waltham, MA
Ortho-Clinical Diagnostics
Class IITerminated
VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Sl...
Reason: Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect p...
Z-2141-2014August 13, 2014Rochester, NY
Brainlab AG
Class IITerminated
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. ...
Reason: The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel ...
Z-2134-2014August 6, 2014Feldkirchen
Mckesson Medical Immaging
Class IITerminated
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digita...
Reason: The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the ima...
Z-2121-2014August 6, 2014Richmond, British Columbia
Philips Ultrasound, Inc.
Class IITerminated
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Reason: The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Z-2109-2014July 30, 2014Bothell, WA
Philips Ultrasound, Inc.
Class IITerminated
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products...
Reason: The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
Z-2110-2014July 30, 2014Bothell, WA
GE Healthcare, LLC
Class ITerminated
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indi...
Reason: Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may...
Z-2068-2014July 30, 2014Waukesha, WI
GE Healthcare, LLC
Class IITerminated
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Reason: Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software v...
Z-2085-2014July 30, 2014Waukesha, WI
Spacelabs Healthcare Inc
Class IITerminated
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentrati...
Reason: With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Z-2077-2014July 23, 2014Snoqualmie, WA
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning a...
Reason: An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the s...
Z-2075-2014July 23, 2014Malvern, PA
Shape Medical Systems, Inc
Class IITerminated
Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardi...
Reason: Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of t...
Z-2051-2014July 23, 2014Saint Paul, MN
Hospira Inc.
Class IITerminated
The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible c...
Reason: Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, ...
Z-2027-2014July 16, 2014Lake Forest, IL
Baxter Healthcare Corp.
Class IITerminated
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR...
Reason: If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It co...
Z-1963-2014July 9, 2014Deerfield, IL
Focus Diagnostics Inc
Class IITerminated
Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M...
Reason: Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer compl...
Z-1958-2014July 9, 2014Cypress, CA
Siemens Medical Solutions USA, Inc.
Class IITerminated
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
Reason: There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.
Z-1962-2014July 9, 2014Mountain View, CA
Nihon Kohden America Inc
Class IITerminated
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Reason: Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 min...
Z-1979-2014July 9, 2014Irvine, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment o...
Reason: There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released, resulting in incorrectly stored data...
Z-1840-2014July 2, 2014Malvern, PA
Baxter Corporation Englewood
Class IITerminated
Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
Reason: Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels ...
Z-1847-2014July 2, 2014Englewood, CO
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoroscopic X-ray system
Reason: When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repeti...
Z-1845-2014July 2, 2014Malvern, PA
Roche Diagnostics Operations, Inc.
Class IITerminated
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully au...
Reason: Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
Z-1790-2014June 25, 2014Indianapolis, IN
Elekta, Inc.
Class IITerminated
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
Reason: A bug in the software prevents the iGUIDE software from logging off.