stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh...
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Reason: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Z-1551-2025April 16, 2025Tarrytown, NY
Tornier S.A.S.
Class IIOngoing
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh...
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh...
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh...
stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoul...
Reason: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance proh...
Reason: Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed fr...
Z-1550-2025April 16, 2025San Diego, CA
Medtronic Neuromodulation
Class IIOngoing
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Reason: There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
Reason: The potential for cracks forming in the breathing circuit hose.
Z-1498-2025April 9, 2025Telford, PA
Draeger, Inc.
Class IOngoing
Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Number: MP01347 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between...
Reason: The potential for cracks forming in the breathing circuit hose.
Z-1494-2025April 9, 2025Telford, PA
Beckman Coulter Inc.
Class IIOngoing
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemi...
Reason: Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are r...
Z-1517-2025April 9, 2025Brea, CA
Draeger, Inc.
Class IOngoing
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 2 Model/Catalog Number: MP02738 Software Version: Not applicable Product Description: Accessory for conducting medical ...
Reason: The potential for cracks forming in the breathing circuit hose.
Z-1496-2025April 9, 2025Telford, PA
Draeger, Inc.
Class IOngoing
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 1 Model/Catalog Number: MP02737 Software Version: Not applicable Product Description: Accessory for conducting medical ...
Reason: The potential for cracks forming in the breathing circuit hose.
Z-1495-2025April 9, 2025Telford, PA
Qiagen Sciences LLC
Class IIOngoing
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Reason: Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
Reason: The potential for cracks forming in the breathing circuit hose.
Z-1499-2025April 9, 2025Telford, PA
Draeger, Inc.
Class IOngoing
Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex 6 Model/Catalog Number: MP02744 Software Version: Not applicable Product Description: Accessory for conducting medical ...
Reason: The potential for cracks forming in the breathing circuit hose.
Z-1497-2025April 9, 2025Telford, PA
Draeger, Inc.
Class IOngoing
Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: MP00355 Software Version: Not applicable Product Description: Breathing circuit for conveying breathing gases between an ...
Reason: The potential for cracks forming in the breathing circuit hose.
Z-1493-2025April 9, 2025Telford, PA
Medtronic Neuromodulation
Class IIOngoing
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Reason: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.