Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.
Reason: Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the ...
Reason: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient l...
Z-2617-2024August 21, 2024Valencia, CA
Thoratec LLC
Class IIOngoing
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 1065...
Reason: Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may ...
Z-2583-2024August 21, 2024Pleasanton, CA
GE Medical Systems, LLC
Class IIOngoing
Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2477-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2464-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2481-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2461-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2473-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2474-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2470-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2483-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2459-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2479-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2482-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2484-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2462-2024August 14, 2024Waukesha, WI
Artivion, Inc
Class IIOngoing
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Reason: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Z-2531-2024August 14, 2024Kennesaw, GA
GE Medical Systems, LLC
Class IIOngoing
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2468-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2467-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2475-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2465-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2480-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2478-2024August 14, 2024Waukesha, WI
GE Medical Systems, LLC
Class IIOngoing
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
Reason: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the foll...
Z-2466-2024August 14, 2024Waukesha, WI
Artivion, Inc
Class IIOngoing
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmon...
Reason: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.