BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human...
Reason: Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2,...
Z-0009-2025October 9, 2024Milpitas, CA
Datascope Corp.
Class IOngoing
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clin...
Z-3134-2024October 2, 2024Mahwah, NJ
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
Reason: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi...
Z-3217-2024October 2, 2024Issaquah, WA
Hologic Inc
Class IIOngoing
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, ...
Reason: Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synt...
Z-3248-2024October 2, 2024Newark, DE
Datascope Corp.
Class IOngoing
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason: Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of ...
Z-3137-2024October 2, 2024Mahwah, NJ
Datascope Corp.
Class IOngoing
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clin...
Reason: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi...
Z-3215-2024October 2, 2024Issaquah, WA
Datascope Corp.
Class IOngoing
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason: Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of ...
Z-3136-2024October 2, 2024Mahwah, NJ
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Reason: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi...
Z-3216-2024October 2, 2024Issaquah, WA
Fisher & Paykel Healthcare, Ltd.
Class IIOngoing
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spont...
Reason: Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happe...
Z-3262-2024October 2, 2024Auckland
Fresenius Kabi USA, LLC
Class IOngoing
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Reason: The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or...
Z-3153-2024October 2, 2024North Andover, MA
Mazor Robotics Ltd
Class IIOngoing
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Reason: Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and t...
Z-3156-2024September 25, 2024Caesarea
Medtronic Inc.
Class IIOngoing
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c...
Reason: Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by softw...
Z-3152-2024September 25, 2024Mounds View, MN
Hitachi America, Ltd., Particle Therapy Division
Class IIOngoing
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic p...
Reason: During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are ...
Z-3125-2024September 18, 2024Santa Clara, CA
Ultradent Products, Inc.
Class IIOngoing
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a ligh...
Reason: Due to a manufacturing issue, red particulates present in the expressed composite.
Reason: Due to a manufacturing issue, red particulates present in the expressed composite.
Z-3066-2024September 18, 2024South Jordan, UT
Hitachi America, Ltd., Particle Therapy Division
Class IIOngoing
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic pro...
Reason: During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are ...
Z-3127-2024September 18, 2024Santa Clara, CA
Ion Beam Applications S.A.
Class IIOngoing
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Reason: Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic p...
Reason: During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are ...
Z-3126-2024September 18, 2024Santa Clara, CA
CareFusion 303, Inc.
Class IIOngoing
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
Reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on...
Z-2947-2024September 11, 2024San Diego, CA
Philips Respironics, Inc.
Class IOngoing
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Tri...
Reason: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier reca...
Reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on...
Z-2948-2024September 11, 2024San Diego, CA
Philips Respironics, Inc.
Class IOngoing
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Reason: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier reca...
Z-2943-2024September 11, 2024Murrysville, PA
Philips Respironics, Inc.
Class IOngoing
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy ...
Reason: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier reca...