Reason: When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not...
Z-0671-2018February 28, 2018Orange City, IA
Fujifilm Medical Systems U.S.A., Inc.
Class IITerminated
Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images t...
Reason: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and ...
Z-0660-2018February 28, 2018Stamford, CT
Oculus Optikgeraete GMBH
Class IITerminated
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to ...
Reason: The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
Z-0635-2018February 28, 2018Wetzlar, N/A
Fujifilm Medical Systems U.S.A., Inc.
Class IITerminated
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mam...
Reason: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and ...
Z-0661-2018February 28, 2018Stamford, CT
Philips Electronics North America Corporation
Class IITerminated
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or...
Reason: Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consen...
Z-0683-2018February 28, 2018Andover, MA
Fujifilm Medical Systems U.S.A., Inc.
Class IITerminated
Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Compute...
Reason: FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and ...
Z-0662-2018February 28, 2018Stamford, CT
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) sy...
Reason: A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw d...
Z-0562-2018February 21, 2018Cleveland, OH
Roche Diabetes Care, Inc.
Class IITerminated
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Reason: Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the uni...
Z-0625-2018February 21, 2018Indianapolis, IN
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Ingenuity Core computed tomography x-ray system
Reason: Numerous issues related to software Brilliance iCT 4.1.6 software version.
Z-0519-2018February 14, 2018Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Ingenuity CT computed tomography x-ray system
Reason: Numerous issues related to software Brilliance iCT 4.1.6 software version.
Z-0521-2018February 14, 2018Cleveland, OH
Cyberonics, Inc
Class IITerminated
VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive t...
Reason: Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
Z-0555-2018February 14, 2018Houston, TX
Spacelabs Healthcare Inc
Class IITerminated
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, M...
Reason: Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
Z-0532-2018February 14, 2018Snoqualmie, WA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Brilliance 64 computed tomography x-ray system
Reason: Numerous issues related to software Brilliance iCT 4.1.6 software version.
Z-0518-2018February 14, 2018Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Philips Ingenuity Core 128 computed tomography x-ray system
Reason: Numerous issues related to software Brilliance iCT 4.1.6 software version.
Z-0520-2018February 14, 2018Cleveland, OH
Edwards Lifesciences, LLC
Class IITerminated
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (H...
Reason: Pre-procedural issues related to software defects
Z-0496-2018February 7, 2018Irvine, CA
Roche Diagnostics Corporation
Class IITerminated
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device...
Reason: A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
Reason: A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
Z-0499-2018February 7, 2018Indianapolis, IN
GE Medical Systems Information Technologies, Inc.
Class IITerminated
GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes phy...
Reason: CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.
Z-0487-2018February 7, 2018Milwaukee, WI
Carl Zeiss Metrology Inc
Class IIOngoing
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
Reason: Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray genera...
Z-0379-2018February 7, 2018Maple Grove, MN
Siemens Medical Solutions USA, Inc
Class IITerminated
Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (P...
Reason: Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Un...
Z-0495-2018February 7, 2018Malvern, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Reason: Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error me...
Z-0403-2018January 31, 2018Cleveland, OH
Smith & Nephew, Inc.
Class IITerminated
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fr...
Reason: In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted ...
Z-0409-2018January 31, 2018Memphis, TN
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Reason: Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error me...
Z-0402-2018January 31, 2018Cleveland, OH
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dos...
Reason: For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed f...
Z-0380-2018January 24, 2018Stockholm, N/A
Roche Diagnostics Corporation
Class IITerminated
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULA...
Reason: Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitatio...