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Summary of Field Safety Notices - January 2022
Notice type:
3rd Party Publications
Date:
01/02/2022
Further Information:
Summary of Field Safety Notices - January 2022
Acutronic Medical Systems AG
fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution - FSN3
Advice regarding a software upgrade. HPRA Ref: V47032
Ambu A/S
Ambu SPUR II for demand valve
Advice regarding a device removal. HPRA Ref: V48350
B.Braun Melsungen AG
Perfusor Space
Advice regarding a device modification. HPRA Ref: V50095
Baxter Healthcare
Transfer Set (MiniCap Extended Life PD Transfer Set (6”) with Twist Clamp)
Advice regarding the use of the device. HPRA Ref: V50191
BÜHLMANN Laboratories AG
Quantum Blue® Anti-Infliximab
Advice regarding a device removal. HPRA Ref: V50090
Chromsystems Instruments & Chemicals GmbH
Analytical column, MassChrom® Free Metanephrines
Advice regarding a device removal. HPRA Ref: V50252
GE Vingmed Ultrasound AS
Vscan Extend
Advice regarding a software upgrade. HPRA Ref: V48365
Hillrom
Traverse Rail Carrier and Traverse Rail Carrier E-System
Advice regarding a device modification. HPRA Ref: V49326
IMMY, Inc
Cryptococcus Antigen Lateral Flow Assay (CrAg LFA) - FSN1
Advice regarding a device removal. HPRA Ref: V50033
Cryptococcus Antigen Lateral Flow Assay (CrAg LFA) - FSN2
Advice regarding a device removal. HPRA Ref: V50033
Intuitive Surgical
Da Vinci Xi and X 12-8 mm Conductive Cannula Reducer
Advice regarding a device removal. HPRA Ref: V48469
Malvern Medical Developments Ltd
Oracol+ Saliva Collection Device
Advice regarding a device removal. HPRA Ref: V50302
Medtronic
Prevail Paclitaxel-coated PTCA balloon catheter
Advice regarding a device removal. HPRA Ref: V48471
Endurant II/Iis Stent Graft System
Advice regarding a device removal. HPRA Ref: V48472
Medtronic Xomed, Inc.
NIM Trivantage™ EMG Endotracheal tube
Advice regarding a device removal. HPRA Ref: V48397
MicroVention
HydroCoil Embolic System - HYDROSOFT 3D
Advice regarding the use of the device. HPRA Ref: V50143
NuVasive Specialised Orthopaedics
MAGEC Device System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V43182
NuVasive Specialised Orthopaedics
Precice IMLL device system
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45559
Philips (Volcano Corporation)
SyncVision System
Advice regarding the use of the device. HPRA Ref: V48293
Roche Diagnostics GmbH
cobas z 480 analyzer - Updated FSN
Advice regarding a device modification. HPRA Ref: V45250
Schiller Medical
Defigard Touch 7
Advice regarding a device modification. HPRA Ref: V42470
Specsavers Optical Superstores Limited
Easyvision Multipurpose contact lens solution
Advice regarding a device removal. HPRA Ref: V49385
Stryker Joint Replacement
Biolox Delta Ceramic V40 Femoral head
Advice regarding a device removal. HPRA Ref: V50296
Ventana Medical Systems Inc
BenchMark ULTRA
Advice regarding a device modification. HPRA Ref: V50173
WelchAllyn
Q-Stress, X-Scribe, H-Scribe, Vision Express, DCS, Connex Cardio, Rscibe Systems
Advice regarding a software upgrade. HPRA Ref: V48896
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Date Printed: 16/04/2024