Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - i...
Reason: Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not...
Z-1688-2024May 1, 2024Nyon, N/A
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB1...
Reason: On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and resul...
Z-1599-2024May 1, 2024Issaquah, WA
SonarMed Inc
Class IOngoing
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Reason: Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Z-1535-2024April 24, 2024Carmel, IN
Philips Respironics, Inc.
Class IOngoing
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Reason: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1505-2024April 24, 2024Murrysville, PA
Philips Respironics, Inc.
Class IOngoing
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Reason: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1503-2024April 24, 2024Murrysville, PA
Philips Respironics, Inc.
Class IOngoing
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Reason: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1502-2024April 24, 2024Murrysville, PA
Philips Respironics, Inc.
Class IOngoing
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Reason: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1504-2024April 24, 2024Murrysville, PA
Philips Respironics, Inc.
Class IOngoing
Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Reason: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1500-2024April 24, 2024Murrysville, PA
Philips Respironics, Inc.
Class IOngoing
Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Reason: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1499-2024April 24, 2024Murrysville, PA
Philips Respironics, Inc.
Class IOngoing
LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Reason: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1501-2024April 24, 2024Murrysville, PA
Philips North America
Class IIOngoing
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
Reason: Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be ...
Z-1507-2024April 17, 2024Cambridge, MA
RAYSEARCH LABORATORIES AB
Class IIOngoing
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Reason: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
Z-1482-2024April 17, 2024Stockholm, N/A
Fresenius Kabi USA, LLC
Class IOngoing
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Reason: Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Z-1484-2024April 17, 2024North Andover, MA
Life Technologies Corporation
Class IIOngoing
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and ...
Reason: Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings,...
Z-1426-2024April 10, 2024Frederick, MD
Philips North America
Class IIOngoing
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Reason: It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
Z-1387-2024April 3, 2024Cambridge, MA
Philips North America
Class IIOngoing
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
Reason: It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
Z-1386-2024April 3, 2024Cambridge, MA
Landauer
Class IICompleted
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
Reason: Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot o...
Z-1349-2024March 27, 2024Glenwood, IL
Fresenius Kabi USA, LLC
Class IICompleted
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Reason: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, res...
Z-1282-2024March 20, 2024North Andover, MA
Fresenius Kabi USA, LLC
Class IICompleted
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Reason: Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is execut...
Z-1283-2024March 20, 2024North Andover, MA
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause ...
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause e...
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is...
Z-1232-2024March 13, 2024Rochester, NY
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause ...
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause e...
Z-1227-2024March 13, 2024Rochester, NY
Ortho-Clinical Diagnostics, Inc.
Class IIOngoing
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause e...