Summary of Field Safety Notices - November 2021

Notice type: 3rd Party Publications

Date: 02/12/2021

 

Product name or type:


Further Information:
Summary of Field Safety Notices - November 2021

Abbott Medical
Amplatzer Steerable Delivery Sheath
Advice regarding the use of the device. HPRA Ref: V47961

Abbott Laboratories - US
ARCHITECT c8000, c16000, i2000SR, i1000SR
Advice regarding the use of the device. HPRA Ref: V47547

Abbott Laboratories -Abbott Park 
ARCHITECT c4000 & ARCHITECT i2000
Advice regarding the use of the device. HPRA Ref: V47546

AMO Ireland
iDESIGN® Refractive Studio & CATALYS™ Precision Laser Operating Systems
Advice regarding a software upgrade. HPRA Ref: V47973

Argon Medical
SuperCore Semi-Automatic Biopsy Instrument
Advice regarding a device removal. HPRA Ref: V47750

B.Braun Medical 
NEXADIA monitor Set, NEXADIA monitor 2 Set
Advice regarding a software upgrade. HPRA Ref: V48005

Baxter Healthcare SA
PrisMax, V2
Advice regarding a software upgrade. HPRA Ref: V47610

bioMérieux Inc
RAPID 20 E™ (Reference 20701)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47931

bioMérieux SA 
VIDAS Immuno-Assays (Multiple references)
Advice regarding the use of the device. HPRA Ref: V47861

Canterbury Scientific Limited
Hemoglobin F and A2 Control
Advice regarding a device modification. HPRA Ref: V47941

Coloplast A/S
Supraflow® supra-pubic drainage set
Advice regarding a device removal. HPRA Ref: V47213

ConvaTec Limited
Avelle™ Negative Pressure Wound Therapy Pump
Advice regarding a device removal. HPRA Ref: V48013

Cordis
SUPER TORQUE® MB Angiographic Catheters (with Marker Bands) - FSN2
Advice regarding the use of the device. HPRA Ref: V47051

D.J.O. LLC
Chattanooga Ultrasound Gels and Lotions
Advice regarding a device removal. HPRA Ref: V47715

Data Innovations LLC 
Instrument Manager
Advice regarding a software upgrade. HPRA Ref: V47622

Datex-Ohmeda, Inc. (GE Healthcare)
Giraffe Incubator, Giraffe Incubator Carestation, Giraffe OmniBed and Giraffe Omnibed Carestation
Advice regarding a device modification. HPRA Ref: V48082

DIXI Medical S.A.S.
MICRODEEP intracerebral electrode
Advice regarding a device removal. HPRA Ref: V48072

EKF-diagnostic GmbH 
ß-Hydroxybutyrate LiquiColor®
Advice regarding a device removal. HPRA Ref: V46984

Fannin Ltd.
W11050 Columbia Blood agar
Advice regarding a device removal. HPRA Ref: V47907

FUJIFILM Irvine Scientific
Vitrification Freeze Kit
Advice regarding the use of the device. HPRA Ref: V47658

GE healthcare Finland Oy
Centricity™ High Acuity Anesthesia / Critical Care
Advice regarding a software upgrade. HPRA Ref: V47896

GE Helathare
Centricity Universal Viewer Zero Footprint client
Advice regarding the use of the device. HPRA Ref: V47985

Getinge
Datascope Cardiosave Hybrid and Cardiosave rescue IABP
Advice regarding a device modification. HPRA Ref: V48145

Intelerad Medical Systems
Incorporated IntelePACS
Advice regarding a software upgrade. HPRA Ref: V47860

Ivor Shaw Ltd. (t/a Pennine Healthcare)
Nasogastric devices (Ryles Tubes, Levins Tubes and Feeding Tubes), Suction Catheters, Rectal Tubes, Nelaton catheters
Advice regarding the use of the device. HPRA Ref: V48049

Leica Microsystems (Schweiz) AG
Leica M220 F12
Advice regarding a device modification. HPRA Ref: V47927

Life Technologies Corporation, a part of Thermo Fisher Scientific 
TaqPath™ COVID-19 CE-IVD RT-PCR Kit
Advice regarding the use of the device. HPRA Ref: V47951

Maquet Cardiopulmonary GmbH
Customized tubing sets
Advice regarding a device removal. HPRA Ref: V47856

Medline
Sterile Surgical Gowns
Advice regarding the use of the device. HPRA Ref: V47749

Sterile Procedure Trays containing Surgical Gowns
Advice regarding the use of the device. HPRA Ref: V47922

Medtronic
Abre Venous Self-Expanding Stent system
Advice regarding the use of the device. HPRA Ref: V47972

Synergy Cranial and Stealthstation Cranial
Advice regarding a software upgrade. HPRA Ref: V48047

Medtronic Inc.
Wireless Rechargers for InterStim Micro, Activa RC, RestoreUltra and RestoreSensor implantable neurostimulators - FSN 1
Advice regarding the use of the device. HPRA Ref: V48067

Wireless Rechargers for InterStim Micro, Activa RC, RestoreUltra and RestoreSensor implantable neurostimulators - FSN 2
Advice regarding the use of the device. HPRA Ref: V48067

Wireless Rechargers for InterStim Micro, Activa RC, RestoreUltra and RestoreSensor implantable neurostimulators - FSN 3
Advice regarding the use of the device. HPRA Ref: V48067 

MOOG
FreeGo Enteral Feeding Pump
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47863

Olympus Medical Systems Corporation
Forceps/Irrigation plug (Isolated type) - MAJ891
Advice regarding the use of the device. HPRA Ref: V48131

PAJUNK GmbH Medizintechnologie
SPROTTE NRFit
Advice regarding a device removal. HPRA Ref: V47915

Philips Medical Systems
BV Endura, BV Pulsera, Veradius Unity
Advice regarding the use of the device. HPRA Ref: V48085

Philips Medical Systems Nederland BV
Philips Allura Xper and Azurion systems
Advice regarding the use of the device. HPRA Ref: V47879

Randox Laboratories Limited
Randox Cholesterol
Advice regarding a device removal. HPRA Ref: V47711

Randox Evidence Investigator
Advice regarding a software upgrade. HPRA Ref: V47892

Siemens
Biograph mCT
Advice regarding the use of the device. HPRA Ref: V47890

The Binding Site Group ltd
Freelite® Human Lambda Free Kit for use on the SPA
Advice regarding the use of the device. HPRA Ref: V47669

Thermo Fisher Scientific
Thermo Scientific™ Campylobacter Test
Advice regarding a device removal. HPRA Ref: V48043


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