Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto...
Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto...
Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto...
Z-1106-2026January 28, 2026Stockholm
MicroPort Orthopedics Inc.
Class IIOngoing
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Reason: Due to products not having FDA Premarket authorization to be distributed within the United States.
Z-1133-2026January 28, 2026Arlington, TN
Sysmex America, Inc.
Class IIOngoing
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Reason: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
Z-1136-2026January 28, 2026Lincolnshire, IL
Edan Diagnostics
Class IIOngoing
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiolo...
Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto...
Z-1103-2026January 28, 2026Stockholm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Philips Azurion system; Software Version Number: R3.1;
Reason: Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrec...
Z-1113-2026January 28, 2026Best
Philips North America
Class IIOngoing
Patient Information Center iX; Software Version Number: 4.5.0
Reason: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Z-1156-2026January 28, 2026Cambridge, MA
LEASEIR TECHNOLOGIES SLU
Class IICompleted
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in g...
Reason: The console label for affected devices is missing the "DANGER" symbol.
Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto...
Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto...
Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto...
Z-1102-2026January 28, 2026Stockholm
Intuitive Surgical, Inc.
Class IIOngoing
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted p...
Reason: Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Z-1134-2026January 28, 2026Sunnyvale, CA
Mazor Robotics Ltd
Class IIOngoing
Mazor X robotic guidance system REF: TPL0059
Reason: Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Z-1122-2026January 28, 2026Caesarea
Edan Diagnostics
Class IIOngoing
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applicatio...
Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto...
Z-1104-2026January 28, 2026Stockholm
Heraeus Medical GmbH (Dental Division)
Class IIOngoing
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (...
Reason: increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule b...
Reason: Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the ...
Reason: increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule b...
Z-1082-2026January 21, 2026Wehrheim
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion ...
Reason: Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor,...
Reason: increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule b...
Reason: increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule b...
Z-1081-2026January 21, 2026Wehrheim
Medtronic Neuromodulation
Class IIOngoing
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
Reason: Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Z-1043-2026January 21, 2026Minneapolis, MN
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class IIOngoing
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azuri...
Reason: Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains i...