Reason: Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Z-1170-2025February 19, 2025Marlborough, MA
Murata Vios, Inc.
Class IIOngoing
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Reason: A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sen...
Reason: Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or c...
Z-1119-2025February 19, 2025San Diego, CA
Elekta, Inc.
Class IIOngoing
MOSAIQ Oncology Information System
Reason: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Z-1162-2025February 19, 2025Atlanta, GA
Sysmex America, Inc.
Class IIOngoing
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cyto...
Reason: Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparatio...
Z-1113-2025February 12, 2025Lincolnshire, IL
Medicrea International
Class IIOngoing
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UN...
Reason: Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on...
Reason: A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Z-1115-2025February 12, 2025Chaska, MN
Fresenius Kabi USA, LLC
Class IOngoing
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted r...
Reason: Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio...
Z-1019-2025February 12, 2025North Andover, MA
LivaNova USA, Inc.
Class IIOngoing
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Sti...
Reason: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Z-1067-2025February 5, 2025Houston, TX
LivaNova USA, Inc.
Class IIOngoing
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Va...
Reason: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Z-1068-2025February 5, 2025Houston, TX
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N54...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0996-2025January 29, 2025Center Valley, PA
Trinity Sterile, Inc.
Class IIOngoing
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 ...
Reason: Potential for hole in package compromising sterility of the medical kit.
Z-1016-2025January 29, 2025Salisbury, MD
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Softw...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0994-2025January 29, 2025Center Valley, PA
Ortho-Clinical Diagnostics, INc.
Class IIOngoing
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Descri...
Reason: The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This ...
Z-1006-2025January 29, 2025Rochester, NY
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N542...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-1000-2025January 29, 2025Center Valley, PA
Trinity Sterile, Inc.
Class IIOngoing
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30...
Reason: Potential for hole in package compromising sterility of the medical kit.
Z-1012-2025January 29, 2025Salisbury, MD
Integrity Implants Inc.
Class IIOngoing
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft ma...
Reason: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Z-1008-2025January 29, 2025Palm Beach Gardens, FL
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N54...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0997-2025January 29, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N54...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0995-2025January 29, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-1001-2025January 29, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-1002-2025January 29, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: ...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-1003-2025January 29, 2025Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N54...
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.