Summary of Field Safety Notices - March 2021

Notice type: 3rd Party Publications

Date: 01/04/2021

 

Further Information:
Summary of Field Safety Notices - March 2021

Abbott
Amplatzer TorqVue Delivery System
Advice regarding a device removal. HPRA Ref: V46048

ASSURITY™ AND ENDURITY™ PACEMAKERS
Advice regarding the use of the device. HPRA Ref: V46153

Accuray
CyberKnife System Standard Treatment Couch
Advice regarding a device modification. HPRA Ref: V46045

Arjo
Maxi Sky 1000 and V10 ceiling lifts
Advice regarding a device modification. HPRA Ref: V45959

Atos Medical AB
Provox Life Night HME, Provox Life Coming Home
Advice regarding the use of the device. HPRA Ref: V46221

B.Braun
AESCULAP Univation X System
Advice regarding a device removal. HPRA Ref: V45979

B.Braun Surgical
HISTOACRYL BLUE, HISTOACRYL LAPFIX, HISTOACRYL PROSET OFX
Advice regarding a device removal. HPRA Ref: V45993

Baxter
COLLEAGUE SINGLE CHANNEL CXE, COLLEAGUE SINGLE CHANNEL MONO, COLLEAGUE TRIPLE CHANNEL CXE, COLLEAGUE TRIPLE CHANNEL MONO
Advice regarding the use of the device. HPRA Ref: V46116

Beckman Coulter Inc 
Access Progesterone DE Calibrators
Advice regarding a device modification. HPRA Ref: V46198

Becton Dickinson and Company
Infusion Sets for Alaris™ Pumps (GP, VP, CC, GW/GW800, SE, IVAC 590 series) and Gravity Infusion sets & connectors
Advice regarding a device removal. HPRA Ref: V45991

bioMerieux SA
VIDAS® CMV IgM
Advice regarding a device removal. HPRA Ref: V45920

VIDAS CMV IgM
Advice regarding a device removal. HPRA Ref: V46194

Biotronik
Subset of IFORIA, INTICA, IFORIA ICDs / CRT-Ds manufactured by Biotronik
Advice regarding the use of the device. HPRA Ref: V45970

Cardinal Health
Kangaroo Enteral Feeding Pump Sets
Advice regarding the use of the device. HPRA Ref: V45669

Cook Medical
Bander Ureteral Diversion Stent Set
Advice regarding a device removal. HPRA Ref: V45969

Depuy
MBT & ATTUNE® Tibial Bases
Advice regarding a device removal. HPRA Ref: V45868

DiaMed GmbH - Cressier 
DiaClon Anti-M/N & DiaClon Anti-N
Advice regarding the use of the device. HPRA Ref: V45877

DiaMed GmbH - Cressier 
DiaClon Anti-M/N & DiaClon Anti-N - FSN Acknowledgement Form
Advice regarding the use of the device. HPRA Ref: V45877

DTR Medical Ltd
Tibbs Arterial Cannula
Advice regarding a device removal. HPRA Ref: V46117

GE Healthcare
Giraffe Shuttle
Advice regarding the use of the device. HPRA Ref: V46084

James Leckey Design Ltd
MyWay Walker
Advice regarding a device modification. HPRA Ref: V46134

LiKAMED GmbH
SELEXA Bed Chair
Advice regarding a device modification. HPRA Ref: V45984

LumiraDx
LumiraDx SARS-CoV-2 Antigen (Ag) Test
Advice regarding a software upgrade. HPRA Ref: V45867

LumiraDx SARS-CoV-2 Antigen (Ag) Test - FSN 1
Advice regarding a device removal. HPRA Ref: V46004

LumiraDx SARS-CoV-2 Antigen (Ag) Test - FSN 2
Advice regarding a device removal. HPRA Ref: V46004

Medtronic
Covidien Signia small diameter curved tip intelligent reload
Advice regarding a device removal. HPRA Ref: V45901

MiniMed 780G and MiniMed 670G - FSN
Advice regarding the use of the device. HPRA Ref: V46155

Activa Clinician Programmer Application
Advice regarding a software upgrade. HPRA Ref: V46160

Activa Clinician Programmer Application
Advice regarding a software upgrade. HPRA Ref: V46161

Surgiwand II Auto Suture Suction and Irrigation Device system
Advice regarding a device removal. HPRA Ref: V45983

Intellis™ Model 97755 Recharger
Advice regarding the use of the device. HPRA Ref: V46234

ARES Antibiotic-Impregnated Catheter
Advice regarding a device removal. HPRA Ref: V46242

Merit Medial
Merit Convenience Kits and Procedure Packs
Advice regarding the use of the device. HPRA Ref: V45729

Microbiologics, Inc.
0726P Candida parapsilosis derived from ATCC® 22019™
Advice regarding a device removal. HPRA Ref: V46121

Mikrogen
ampliCube Coronavirus SARS-CoV-2
Advice regarding a device removal. HPRA Ref: V45240

Nutricia
Flocare® Infinity™ II enteral feeding pumps
Advice regarding changes/updates made to instructions for use. HPRA Ref: V46179

Olympus
GASTROINTESTINAL VIDEOSCOPE GIF-EZ1500/COLONOVIDEOSCOPE CF-EZ1500DI & CF-EZ1500DL
Advice regarding a device removal. HPRA Ref: V45628

Olympus Duodenoscopes TJF-Q170V, TJF-Q190V & TJF-Q290V & Single use Distal Cover MAJ-2315
Advice regarding the use of the device. HPRA Ref: V45894

Omnia Srl
Soft Tissue Punch
Advice regarding a device removal. HPRA Ref: V46241

Partners for Endoscope Medical
ScopeFlow water bottle tubing product
Advice regarding a device modification. HPRA Ref: V45852

Pharmed
Nasopure Nasal Wash
Advice regarding a device removal. HPRA Ref: V45672

Radiometer Medical ApS
AQT90 FLEX Analyzers - FSN updated 1
Advice regarding the use of the device. HPRA Ref: V45363

Radiometer Medical ApS
AQT90 FLEX Analyzers - FSN updated 2
Advice regarding the use of the device. HPRA Ref: V45363

Roche
Elecsys CA 19-9
Advice regarding the use of the device. HPRA Ref: V42751

cobas® SARS-CoV-2 & Influenza A/B Test
Advice regarding the use of the device. HPRA Ref: V46210

Roche Diagnostics
Various Cobas Products
Advice regarding the use of the device. HPRA Ref: V45304

ALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3) - FSN 3
Advice regarding the use of the device. HPRA Ref: V41233

ALB2 (Albumin Gen.2), BILT3 (Bilirubin Total Gen.3) - FSN 4
Advice regarding the use of the device. HPRA Ref: V41233

Siemens Healthcare Diagnostics Inc.
ADVIA 2120/2120i Hematology System
Advice regarding the use of the device. HPRA Ref: V45940

Siemens Healthcare Medical Solutions Limited
ARTIS icono and ARTIS pheno
Advice regarding a software upgrade. HPRA Ref: V46209

Sirona dental systems GmbH
Intego dental chair
Advice regarding a device modification. HPRA Ref: V46159

Somatex
Biopsy Handy & Puncture Sheath
Advice regarding the use of the device. HPRA Ref: V46240

Safe Cut, Bone Marrow, Marrow Cut, MR Safe Cut
Advice regarding a device removal. HPRA Ref: V46260

Teleflex
Arrow® OnControl® Bone Lesion Biopsy System Tray
Advice regarding a device removal. HPRA Ref: V46041

Weinmann Medical Technology
MEDUMAT Transport
Advice regarding a software upgrade. HPRA Ref: V46043


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