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Summary of Field Safety Notices- November 2023
Notice type:
3rd Party Publications
Date:
05/12/2023
Further Information:
Abbott Diagnostics Scarborough, Inc.
ID NOW™ Instrument
Advice regarding a software upgrade. HPRA Ref: CRN00DX05
Ambu A/S
Ambu® aView 2 Advance
Advice regarding the use of the device. HPRA Ref: CRN00DY1R
B. Braun Medical Ltd
Standard and customer specific Combitrans/Combidyn
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DZ74
BioFire Diagnosticss, LLC
BIOFIRE FILMARRAY TORCH
Advice regarding the use of the device. HPRA Ref: CRN00DXRM
bioMérieux UK Ltd
BIOFIRE® Blood Culture Identification 2 (BCID2) Panel
Advice regarding the use of the device. HPRA Ref: CRN00DXQ4
Caesarea Medical Electronics Ltd.
BodyGuard™ Infusion Pumps Systems (LVP)
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DZ51
CamDiab Ltd
CamAPS and mylife CamAPS. User FSN
CamAPS and mylife CamAPS. DHCP FSN
Advice regarding a software upgrade. HPRA Ref: CRN00DYL7
Cepheid
Xpert® Xpress Strep A
Advice regarding the use of the device. HPRA Ref: CRN00DYL3
Cepheid Europe SAS
Xpert Xpress CoV-2/Flu/RSV plus
Advice regarding the use of the device. HPRA Ref: CRN00DXQW
Covidien llc
Kangaroo Enteral Feeding Pump Sets. FSN 1
Kangaroo Enteral Feeding Pump Sets. Attachment A
Advice regarding the use of the device. HPRA Ref: CRN00DYFP
Covidien llc
Valleylab™ FT10 FT Series Energy Platform
Advice regarding a software upgrade. HPRA Ref: CRN00DY99
Drägerwerk AG & Co. KGaA
Atlan Family
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DYW0
FEATHER® Safety Razor Co. Ltd.
Standard Incision Scalpel
Advice regarding a device removal. HPRA Ref: CRN00DW9J
GE Hualun Medical Systems Co. Ltd
Definium Tempo - Definium Tempo Pro
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DYFG
Illumina
NextSeq 550Dx Instrument
Advice regarding a software upgrade. HPRA Ref: V51267
Maquet Cardiopulmonary GmbH
Cardiohelp-i
Advice regarding the use of the device. HPRA Ref:CRN00DYGL
Maquet Cardiopulmonary GmbH
Cardiohelp-i
Advice regarding a device modification. HPRA Ref: CRN00DXQM
Medtronic
LINQ™II Insertable Cardiac Monitor
Advice regarding a device removal. HPRA Ref: CRN00DXW0
Medtronic Inc.
Cobalt XT, Cobalt, Crome, Viva™, Brava™, Evera™, Evera MRI SureScan, Visia AF™, Visia AF MRI™ SureScan™, Primo MRI™, Mirro MRI™ SureScan™, Claria MRI™, Amplia MRI™, Compia MRI™ CRT-D
Advice regarding a software upgrade. HPRA Ref: V55139
Medtronic MiniMed
Guardian™ 4 Sensor. FSN User
Guardian™ 4 Sensor. FSN HCP
Advice regarding a device removal. HPRA Ref: CRN00DYG3
Medtronic Xomed Inc.
NIM Trivantage™ EMG Endotracheal tube
Advice regarding a device removal. HPRA Ref: CRN00DY6W
Medtronic, Inc.
SynchroMed™ II
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DZ1C
Molecular Diagnostics at Abbott
Alinity m HCV AMP Kit
Advice regarding a device removal. HPRA Ref: CRN00DXSG
mo-vis bv
Scoot Controls R-net, Scoot Controls LiNX
Advice regarding the use of the device. HPRA Ref: CRN00DXYW
Olympus Medical Systems Corporation
OLYMPUS TJF-Q190V/Q290V/Q170V DUODENOSCOPE
Advice regarding the use of the device. HPRA Ref: CRN00DYZ0
Olympus Medical Systems Corporation
High Flow Inssuflation Unit UHI-4
Advice regarding the use of the device. HPRA Ref: CRN00DVKW
Olympus Winter & Ibe GmbH
Endoeye HD II
Advice regarding the use of the device. HPRA Ref: CRN00DYP3
Philips Healthcare
Philips Intera, Achieva, Ingenia CX
Advice regarding the use of the device. HPRA Ref: CRN00DXGT
Philips Medical Systems Nederland BV
Philips Azurion, Philips Allura
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DXV2
Philips Respironics, Inc.
Trilogy Evo and Trilogy Evo O2 ventilators
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DZ81
QuidelOrtho (Ortho Clinical Diagnostics Inc)
ORTHO VISION and VISION Max Analyzers for BioVue
Advice regarding the use of the device. HPRA Ref:CRN00DXQ1
Randox Laboratories Ltd
Calibration Serum Level 3, Human Assayed Multi-Sera Level 2, Human Assayed Multi-Sera Level 3
Advice regarding a device modification. HPRA Ref: CRN00DYH6
Randox Laboratories Ltd.
Randox Serology ToRCH IgM Positive Control
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DXSR
Remote Diagnostic Technologies Ltd.
Tempus Pro
Advice regarding a software upgrade. HPRA Ref: CRN00DST2
ResMed
ResMed Masks with Magnets
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DYMZ
Schiller Medical
DEFIGARD Touch-7
Advice regarding a software upgrade. HPRA Ref: CRN00DYF9
Siemens Healthcare Diagnostics Inc.
RAPIDPoint 500 Systems Measurement Cartridge
Advice regarding the use of the device. HPRA Ref: CRN00DXLS
Siemens Healthineers
Sensis or Sensis Vibe with VD15B
Advice regarding a software upgrade. HPRA Ref: CRN00DZJR
Smiths Medical
Medfusion™ Model 3500 Syringe Infusion Pump
Advice regarding a software upgrade. HPRA Ref: CRN00DZ7P
Smiths Medical
Medfusion™ Model 4000 Syringe Infusion Pump
Advice regarding a software upgrade. HPRA Ref: CRN00DZ7Y
VOSTRA GmbH
Rhinotamp®, Rhinotamp® latexfrei
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DZMX
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Date Printed: 30/04/2024