Reason: The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security b...
Z-2329-2018July 4, 2018Sylmar, CA
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy....
Reason: The dose calculation accuracy may in some situations be less than expected. The user must be aware in order to avoid incorrect dose calculations during treatment planning.
Z-2290-2018July 4, 2018Stockholm
Datex-Ohmeda, Inc.
Class IITerminated
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult pati...
Reason: Potential for the display processor to experience an unexpected failure.
Z-2266-2018June 27, 2018Madison, WI
Cyberonics, Inc
Class IITerminated
VNS Therapy Programmer, Model 3000, v1.0 System
Reason: Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the misca...
Reason: Five warning statements are missing from the instructions for use.
Z-2144-2018June 20, 2018Andover, MA
Roche Diagnostics Corporation
Class IITerminated
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is p...
Reason: The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to ...
Reason: Five warning statements are missing from the instructions for use.
Z-2143-2018June 20, 2018Andover, MA
Cellavision AB
Class IIOngoing
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The ...
Reason: A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides...
Reason: Five warning statements are missing from the instructions for use.
Z-2142-2018June 20, 2018Andover, MA
Randox Laboratories
Class IITerminated
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Reason: Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
Z-2059-2018June 13, 2018Kearneysville, WV
NordicNeuroLab AS
Class IITerminated
nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a stan...
Reason: The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Any output created from these activation maps as overlays will not...
Z-2061-2018June 13, 2018Bergen, N/A
MEDTECH SAS
Class IITerminated
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positio...
Reason: Replacement of units lacking an updated device approval.
Z-2108-2018June 13, 2018Montpellier, N/A
Ion Beam Applications S.A.
Class IITerminated
12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with re...
Reason: IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
Z-2109-2018June 13, 2018Louvain La Neuve, N/A
Orthofix Srl
Class IITerminated
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates...
Reason: The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manuf...
Z-2063-2018June 13, 2018Bussolengo, N/A
NordicNeuroLab AS
Class IITerminated
nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software...
Reason: There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been sel...
Z-2045-2018June 6, 2018Bergen, N/A
NordicNeuroLab AS
Class IITerminated
nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a...
Reason: An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-po...
Z-2042-2018June 6, 2018Bergen, N/A
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
Reason: There is a potential for a software issue that may cause the need for necessary patient rescans.
Z-1939-2018June 6, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Reason: There is a potential for a software issue that may cause the need for necessary patient rescans.
Z-1940-2018June 6, 2018Malvern, PA
NordicNeuroLab AS
Class IITerminated
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Reason: An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-po...
Z-2044-2018June 6, 2018Bergen, N/A
Beckman Coulter Inc.
Class IITerminated
iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine ch...
Reason: The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
Reason: Software anomaly resulting in the loss of patient settings and stored patient data.
Z-1813-2018May 23, 2018Andover, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
Reason: There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMA...
Z-1746-2018May 23, 2018Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
Reason: There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMA...