Reason: The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gast...
Reason: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Z-1922-2024June 5, 2024Fort Worth, TX
Stryker Orthopaedics
Class IIOngoing
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+...
Reason: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when ...
Z-1913-2024June 5, 2024Montclair, NJ
Reflexion Medical, Inc.
Class IIOngoing
RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a...
Reason: A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Reason: There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Z-1919-2024June 5, 2024Loveland, CO
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
Reason: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table...
Z-1897-2024June 5, 2024Best
Stryker Orthopaedics
Class IIOngoing
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1...
Reason: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when ...
Z-1915-2024June 5, 2024Montclair, NJ
Stryker Orthopaedics
Class IIOngoing
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4....
Reason: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when ...
Z-1911-2024June 5, 2024Montclair, NJ
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
Reason: Potential for pressure wave data synchronization from two devices may not be correct.
Reason: The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gast...
Z-1900-2024June 5, 2024Foxboro, MA
Stryker Orthopaedics
Class IIOngoing
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4....
Reason: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when ...
Reason: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Reason: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Z-1923-2024June 5, 2024Fort Worth, TX
Stryker Leibinger GmbH & Co. KG
Class IIOngoing
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons h...
Reason: Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer o...
Z-1885-2024May 29, 2024Freiburg Im Breisgau
Tornier S.A.S.
Class IIOngoing
Stryker Blueprint Software, Catalog #BPUE001.
Reason: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible ...
Z-1883-2024May 29, 2024Montbonnot St Martin
Philips North America Llc
Class IIOngoing
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
Reason: Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Z-1830-2024May 22, 2024Cambridge, MA
Philips North America Llc
Class IIOngoing
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Reason: Event Catalog information does not save when copied and transferred from one unit to another.
Z-1827-2024May 22, 2024Cambridge, MA
Philips North America Llc
Class IIOngoing
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
Reason: Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Z-1829-2024May 22, 2024Cambridge, MA
Medtronic Navigation, Inc.
Class IOngoing
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical p...
Reason: Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Z-1776-2024May 15, 2024Lafayette, CO
Randox Laboratories Ltd.
Class IIIOngoing
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
Reason: Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled De...
Z-1786-2024May 15, 2024Crumlin (North), N/A
Advanced Instruments, LLC
Class IIOngoing
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX So...
Reason: System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
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-1686-2024May 1, 2024Nyon, N/A
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
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-1601-2024May 1, 2024Issaquah, WA
Siemens Medical Solutions USA, Inc.
Class IIOngoing
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
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-1600-2024May 1, 2024Issaquah, WA
Electro Medical Systems SA
Class IIOngoing
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort ...
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...