Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and al...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0944-2020February 26, 2020Murrysville, PA
Philips Respironics, Inc.
Class ITerminated
LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm ...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0954-2020February 26, 2020Murrysville, PA
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and al...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0953-2020February 26, 2020Murrysville, PA
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, an...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0952-2020February 26, 2020Murrysville, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has med...
Reason: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Z-1338-2020February 26, 2020Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical...
Reason: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Z-1337-2020February 26, 2020Malvern, PA
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and al...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0948-2020February 26, 2020Murrysville, PA
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, an...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0942-2020February 26, 2020Murrysville, PA
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and ala...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0949-2020February 26, 2020Murrysville, PA
Philips Respironics, Inc.
Class ITerminated
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0946-2020February 26, 2020Murrysville, PA
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0951-2020February 26, 2020Murrysville, PA
Philips Medical Systems Gmbh, DMC
Class IIOngoing
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Reason: When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Addition...
Z-1328-2020February 26, 2020Hamburg
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm S...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0945-2020February 26, 2020Murrysville, PA
Philips Respironics, Inc.
Class ITerminated
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, ...
Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all p...
Z-0947-2020February 26, 2020Murrysville, PA
MEDTECH SAS
Class IITerminated
ROSA Brain 3.0 Application-Brain
Reason: Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain soft...
Z-1150-2020February 19, 2020Montpellier
Philips North America, LLC
Class IITerminated
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion...
Reason: Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
Z-1145-2020February 19, 2020Andover, MA
Dexcom Inc
Class IITerminated
Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
Reason: It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days af...
Z-1104-2020February 19, 2020San Diego, CA
Blue Ortho
Class IITerminated
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Reason: The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Z-1149-2020February 19, 2020Gieres
MEDTECH SAS
Class IITerminated
ROSA One 3.1 Brain Application
Reason: Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain soft...
Z-1151-2020February 19, 2020Montpellier
Biomerieux Inc
Class IITerminated
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
Reason: Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. Indeed, the calibrations of assay...
Z-0928-2020February 12, 2020Hazelwood, MO
Dexcom Inc
Class IITerminated
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determi...
Reason: It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powerin...
Reason: Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component...
Reason: Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an in...
Z-0866-2020February 5, 2020Stockholm, N/A
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vit...
Reason: On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) ...
Z-0862-2020February 5, 2020Tarrytown, NY
Koios Medical, Inc.
Class IITerminated
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Reason: Affected software product versions were found during internal audit to have been marketed for sale without sufficient documentation pertaining to certain required quality procedure...