Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Z-1346-2026February 18, 2026Best, N/A
Elekta, Inc.
Class IIOngoing
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for L...
Reason: Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea...
Z-1340-2026February 18, 2026Atlanta, GA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Z-1347-2026February 18, 2026Best, N/A
Elekta, Inc.
Class IIOngoing
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell...
Reason: Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a trea...
Z-1339-2026February 18, 2026Atlanta, GA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Z-1351-2026February 18, 2026Best, N/A
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Z-1348-2026February 18, 2026Best, N/A
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Z-1350-2026February 18, 2026Best, N/A
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Z-1349-2026February 18, 2026Best, N/A
Fujirebio Diagnostics, Inc.
Class IIOngoing
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma...
Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back ...
Z-1303-2026February 11, 2026Malvern, PA
Medtronic MiniMed, Inc.
Class IIOngoing
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose ...
Reason: A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delive...
Z-1238-2026February 11, 2026Northridge, CA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus en...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1272-2026February 11, 2026Center Valley, PA
Fujirebio Diagnostics, Inc.
Class IIOngoing
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product ...
Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back ...
Z-1304-2026February 11, 2026Malvern, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus en...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1276-2026February 11, 2026Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be us...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1281-2026February 11, 2026Center Valley, PA
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinc...
Reason: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Uni...
Z-1232-2026February 11, 2026Sunnyvale, CA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be us...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1297-2026February 11, 2026Center Valley, PA
Fujirebio Diagnostics, Inc.
Class IIOngoing
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma ...
Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back ...
Z-1305-2026February 11, 2026Malvern, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus en...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1274-2026February 11, 2026Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be us...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1278-2026February 11, 2026Center Valley, PA
Focalyx Technologies, LLC.
Class IIOngoing
Focalyx Fusion
Reason: Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh...
Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Z-1242-2026February 11, 2026Malvern, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus en...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Z-1240-2026February 11, 2026Malvern, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus en...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1275-2026February 11, 2026Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus en...
Reason: Devices which did not undergo thermoforming could deform and lose performance.