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Summary of Field Safety Notices - April 2020

Notice type: 3rd Party Publications

Date: 05/05/2020

  

Further Information:
Summary of Field Safety Notices - April 2020

Abbott
Afinion 2 and Alere Afinion AS100 Analyzers
Advice regarding a device modification. HPRA Ref: V43275

Apyx Medical (formerly Bovie Medical)
Renuvio/ J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise open handpiece
Advice regarding the use of the device. HPRA Ref: V43544

Asid Bonz GmbH
Non-Woven Disposable Surgical Gowns
Advice regarding the use of the device. HPRA Ref: V43585

Becton Dickinson
BD PosiFlush™ XS 10mL Syringe
Advice regarding the use of the device. HPRA Ref: V43477

BD BBL™ Gram Crystal Violet 250mL & Grain Stain Kit
Advice regarding a device removal. HPRA Ref: V43501

Bentley InnoMed
BeGraft Coronary Stent Graft System
Advice regarding a device removal. HPRA Ref: V43545

DiaSys Diagnostic Systems GmbH
Bilirubin Auto Direct FS, Bilirubin Auto Total FS, Creatinine FS, Creatinine PAP FS
Advice regarding the use of the device. HPRA Ref: V43589

Gambro Dasco
Artiset Tubing Sets - ARTISET HD DNL HC - FSN 1
Advice regarding the use of the device. HPRA Ref: V43606

Artiset Tubing Sets - ARTISET HD DNL HC - Attachment 1
Advice regarding the use of the device. HPRA Ref: V43606

Artiset Tubing Sets - ARTISET HD DNL HC - Attachment 2 
Advice regarding the use of the device. HPRA Ref: V43606

GE Healthcare
Carescape One
Advice regarding a software upgrade. HPRA Ref: V43687

GSE sro
Combilte
Advice regarding the use of the device. HPRA Ref: V43656

LeMaitre Vascular
Over Wire Embolectomy Catheter
Advice regarding a device removal. HPRA Ref: V43303

NuVasive Inc.
NuVasive MAGEC Spinal system- all iterations
Advice regarding the use of the device. HPRA Ref: V43128

Philips
TraumaDiagnost
Advice regarding a device modification. HPRA Ref: V43464

Internal Sterilizable Defibrillator paddles
Advice regarding the use of the device. HPRA Ref: V43530

HeartStart XL Defibrillator/Monitor
Advice regarding a device removal. HPRA Ref: V43490

Radiometer Medical
AQT90 FLEX analyzers
Advice regarding a software upgrade. HPRA Ref: V43450

Schiller AG
medilogAR
Advice regarding a software upgrade. HPRA Ref: V43637

Siemens
AXIOM Multix MT / AXIOM Vertix Solitaire M, Ysio and Ysio MAX,  MD Trauma, AXIOM MULTIX M / TOP / Pro, AXIOM Aristos MX/VX, Multix Fusion, Sireskop SD, 
Iconos R200, LuminosTF, Luminos Agile (Max), Luminos dRF (Max), Luminos Fusion / MD Trauma, AXIOM MULTIX M / TOP / Pro, AXIOM Aristos MX/VX, Multix Fusion, Ysio (Max), Sireskop SD, Iconos R200, LuminosTF, Luminos Agile (Max), Luminos dRF (Max), Luminos Fusion - FSN 1
Advice regarding a device modification. HPRA Ref: V36732

AXIOM Multix MT / AXIOM Vertix Solitaire M, Ysio and Ysio MAX,  MD Trauma, AXIOM MULTIX M / TOP / Pro, AXIOM Aristos MX/VX, Multix Fusion, Sireskop SD, 
Iconos R200, LuminosTF, Luminos Agile (Max), Luminos dRF (Max), Luminos Fusion / MD Trauma, AXIOM MULTIX M / TOP / Pro, AXIOM Aristos MX/VX, Multix Fusion, Ysio (Max), Sireskop SD, Iconos R200, LuminosTF, Luminos Agile (Max), Luminos dRF (Max), Luminos Fusion - FSN 2
Advice regarding a device modification. HPRA Ref: V36732

AXIOM Multix MT / AXIOM Vertix Solitaire M, Ysio and Ysio MAX,  MD Trauma, AXIOM MULTIX M / TOP / Pro, AXIOM Aristos MX/VX, Multix Fusion, Sireskop SD, 
Iconos R200, LuminosTF, Luminos Agile (Max), Luminos dRF (Max), Luminos Fusion / MD Trauma, AXIOM MULTIX M / TOP / Pro, AXIOM Aristos MX/VX, Multix Fusion, Ysio (Max), Sireskop SD, Iconos R200, LuminosTF, Luminos Agile (Max), Luminos dRF (Max), Luminos Fusion - FSN 3
Advice regarding a device modification. HPRA Ref: V36732

Siemens Healthcare Diagnostics
Atellica CH 930 Reaction Cuvette Segment - FSN 3
Advice regarding the use of the device. HPRA Ref: V42624

Atellica CH 930 Reaction Cuvette Segment - FSN 4
Advice regarding the use of the device. HPRA Ref: V42624

Smith & Nephew
R3 Acetabular Shells
Advice regarding a device removal. HPRA Ref: V43596

The Binding Site Group
Optilite Analyser
Advice regarding a software upgrade. HPRA Ref: V43465

ZeptoMetrix Corporation
Natrol Stapylococcus aureus (SA) Positive Control
Advice regarding a device removal. HPRA Ref: V43605

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