3M ESPE
3M™ ESPE™ Lava™ Ultimate CAD/CAM Restorative - Letter 1 3M™ ESPE™ Lava™ Ultimate CAD/CAM Restorative - Letter 2
Advice regarding changes/updates made to instuctions for use. HPRA Ref: V24561
American Medical Systems
SureFlex™ Reusable Fibers and Reusable Stripper and Cleaver Accessories
Advice regarding a device removal. HPRA Ref: V24638
Animas
Animas Vibe Insulin Pump - Letter 1 Animas Vibe Insulin Pump - Letter 2
Advice regarding the use of the device. HPRA Ref: V24730
B.Braun Medical Limited
4 Ganged Ultraport HF Stopcock
Advice regarding a device removal. HPRA Ref: V25017
Baxter Healthcare SA
Sterile Water for Irrigation, 1000mL & 0.9% Sodium Chloride for Irrigation
Advice regarding a device removal. HPRA Ref: V24781
BrianLab AG
iPlan RT Dose
Advice regarding a software upgrade. HPRA Ref: V24779
Clinical Innovations
Ebb complete Tamponade System (CTS-1000)
Advice regarding a device removal. HPRA Ref: V24819
Cook Medical Europe
Beacon Tip Angiographic Catheters
Advice regarding a device removal. HPRA Ref: V24812
DePuy Orthopaedics, Inc.
RECLAIM® Assembled Implant Inserter Adaptor
Advice regarding a device removal. HPRA Ref: V23823
DePuy Synthes
ATTUNE® INTUITION™ Tibial Articulation Surface Instruments
Advice regarding the use of the device. HPRA Ref: V24839
GE Healthcare
T2100 and T2000 Treadmill Power cords
Advice regarding a device modification. HPRA Ref: V23947
GE Healthcare
T2100 Treadmill
Advice regarding a device modification. HPRA Ref: V23952
GE Healthcare
Centricity PACS-IW with Universal Viewer version 5.0Sp6 or higher customers.
Advice regarding a software upgrade. HPRA Ref: V24425
GE Healthcare
Precision 500D and Advantx Legacy/Legacy-D Radiographic and Flouroscopic Systems
Advice regarding a device modification. HPRA Ref: V24729
Integral Medical Products
Fannin Silicone Laryngeal Mask
Advice regarding the use of the device. HPRA Ref: V25015
Invacare
Reliant 350 Lifter
Advice regarding a device modification. HPRA Ref: V24824
Jotec
E-tegra Stent Graft System
Advice regarding a device removal. HPRA Ref:V25065
Medcomp
Medcomp Hemo-Cath LT and Hemo-Cath ST Hemodialysis Catheters
Advice regarding the use of the device. HPRA Ref: V24760
Medtronic
KYPHON® 11 Gauge Bone Access Needle (Model A02A)
Advice regarding a device removal. HPRA Ref: V24714
Medtronic
EnVeo™ R Loading System. Model Numbers: LS-EnVeoR-23 and LS-EnVeoR-2629
Advice regarding a device removal. HPRA Ref: V24860
Northern Digital Inc. (NDI)
NDI Disposable Reflective Marker Spheres
Advice regarding the use of the device. HPRA Ref: V24673
Ortho-Clinical Diagnostics
VITROS® 5,1 FS Chemistry Systems
Advice regarding a software upgrade. HPRA Ref: V24773
Össur
Prosthestic Feet - Talux®, Vari-Flex®, Vari-Flex® XC, Re-Flex Shock™, Re-Flex Rotate™, Flex-Foot® Assure™, Balance™ Foot J
Advice regarding a device modification. HPRA Ref: V24874
Philips Healthcare
Ingenuity CT, Ingenuity Core, Ingenuity Core128 With Continuous Computed Tomography (CCT) Option and have been Upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1
Advice regarding a software upgrade. HPRA Ref: V22089
Philips Healthcare
Sense Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR Systems
Advice regarding the use of the device. HPRA Ref: V24789
Philips Healthcare
HeartStart XL+
Advice regarding a software upgrade. HPRA Ref: V24898
Philips Healthcare
Allura Systems - Actuator Monitor Ceiling Suspension
Advice regarding a device modification. HPRA Ref: V25049
Philips Medical Systems
TraumaDiagnost
Advice regarding a device modification. HPRA Ref: V25081
Pulsion Medical Systems
PiCCO Catheter
Advice regarding a device removal. HPRA Ref: V24844
Q Core Medical Limited
Sapphire Infusion Pump
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24899
Roche Diagnostics
S3 Fluid Pack A and S2 Fluid Pack
Advice regarding the use of the device. HPRA Ref: V24364
Roche Diagnostics
Reflotron Uric Acid, Reflotron PST Uric Acid, and Reflotron Uric Acid II
Advice regarding the use of the device. HPRA Ref: V24784
Siemens
RAPIDPoint® 500 System
Advice regarding a device modification. HPRA Ref: V25064
Siemens
syngo RT Oncologist with software version 4.2.X or 4.3.X
Advice regarding a software upgrade. HPRA Ref: V25071
Siemens
E.cam
Advice regarding a device modification. HPRA Ref: V24804
Siemens AG
Artis Systems with software version VC14J
Advice regarding a software upgrade. HPRA Ref: V24759
Siemens AG
Acuson S Family (S1000, S2000, S3000)
Advice regarding a software upgrade. HPRA Ref: V24766
Siemens AG
Acuson S Family ultrasound systems utilising the 18L6 HD and 6C1 HD biopsy guidelines
Advice regarding the use of the device. HPRA Ref: V24782
Siemens AG
Artis zee Floorstand, Artis zee Biplane Floorstand and Artis zee Multi Purpose systems with SW version VC14J
Advice regarding a software upgrade. HPRA Ref: V24837
Siemens Healthcare Diagnostics
Dimension Creatinine (CREA)
Advice regarding the use of the device. HPRA Ref: V24900
Sorin Group
Sorin Group perfusion system - Heater Cooler 1T and Heater Cooler 3 T
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24452
Stryker Neurovascular
Target Detachable Coils
Advice regarding a device removal. HPRA Ref: V24063
Synthes GmbH
Oscillating Saw Attachement for Colibri / Colibri II / Small Electric Drive
Advice regarding the use of the device. HPRA Ref: V23939
Vygon
Y connector code 884.08
Advice regarding a device removal. HPRA Ref: V24718
Vygon
20 ml Vygon Nutrisafe C-GON Enteral syringes code 1015.202 batch G86115-2
Advice regarding a device removal. HPRA Ref: V24737
Wallac Oy
LifeCycle for Prenatal Screening
Advice regarding a software upgrade. HPRA Ref: V24435
Zefon International, Inc.
Infuse IT Manual Pressure Infusor
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23520
Zethon Limited
Fibrillation Cable - REM-DF02, REM-DF04, REM-DF06, REM-DF07
Advice regarding a device removal. HPRA Ref: V24616
Zethon Limited
Bipolar forceps with irrigation - REM-101, REM-101-D, REM-101-SP, REM-102, REM-102-D, REM-103, REM-103-D, REM-104, REM-104-D, REM-105, REM-105-D
Advice regarding a device removal. HPRA Ref: V24617
Zethon Limited
Forceps, Sterile
Advice regarding a device removal. HPRA Ref: V24802
Zethon Limited
Electrodes, Sterile, Single Use
Advice regarding a device removal. HPRA Ref: V24927