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Summary of Field Safety Notice – November 2016
Notice type:
3rd Party Publications
Date:
05/12/2016
Further Information:
Abbott
ARCHITECT Toxo IgM
Advice regarding the use of the device. HPRA Ref: V29953
AbbVie
AbbVie PEG 20FR Tube
Advice regarding the use of the device. HPRA Ref: V29892
Bausch & Lomb
EasySept Hydro Plus Peroxide Solution
Advice regarding the use of the device. HPRA Ref: V29785
Becton Dickinson GmbH
BD Plastipak / Oral Syringes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30050
Biomerieux
NucliSENS® easyMAG® Magnetic Silica; NucliSENS® Magnetic Extraction Reagents
Advice regarding the use of the device. HPRA Ref: V30049
Bosch + Sohn GmbH u.Co.KG
Boso TM-2430 PC2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V29829
Caesarea Medical Electronics
CME Ambulatory Syringe Pumps - T34, T60 and TPCA
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26596
Conecert Medical
Coronary Guidewire
Advice regarding a device removal. HPRA Ref: V29960
DEAS S.R.L
DEAS Autofeed Humidification Chamber
Advice regarding changes/updates made to instructions for use. HPRA Ref: V28430
GE Healthcare
Avance CS2, Avance, and Amingo
Advice regarding a device modification. HPRA Ref: V30030
Global Components Medical LTD
Total intravenous anaesthesia sets (TIVA)
Advice regarding a device modification. HPRA Ref: V29776
Intuitive Surgical
da Vinci Xi Surgical System P5 Software
Advice regarding a device modification. HPRA Ref: V29733
Kasios
KAGE, Kasios TCP, RSF
Advice regarding a device removal. HPRA Ref: V29900
Laerdal Medical
Laerdal Compact Suction Unit® 4 (LCSU® 4)
Advice regarding the use of the device. HPRA Ref: V30056
MacoPharma
NPT6280LA LCRD2 Filter
Advice regarding the use of the device. HPRA Ref: V30062
Medtronic
NIM® Standard and NIM Contact® Reinforced EMG Endotracheal Tubes.
Advice regarding changes/updates made to instructions for use. HPRA Ref: V28265
METsis Medikal
Life-Point Pro/bPLUS/mPLUS AEDs
Advice regarding a software upgrade. HPRA Ref: V29146
Nihon Kohden Europe GmbH
Cardiolife AED-2100k
Advice regarding a software upgrade. HPRA Ref: V29890
Origio a/s
Quinn’s Advantage Medium with Hepes
Advice regarding a device remova. HPRA Ref: V29980
Ortho Clinical Diagnostics
Ortho Reagent Red Blood Cell (RRBC) products & Quality Control products containing red blood cells
Advice regarding the use of the device. HPRA Ref: V30096
Ortho Clinical Diagnostics
Ortho Reagent Red Blood Cell (RRBC) products & Quality Control products containing red blood cells
Advice regarding the use of the device. HPRA Ref: V30096
Oscor (Medtronic)
ARRIVE™ Braided Transseptal Sheath
Advice regarding a device removal. HPRA Ref: V29855
Randox
Glucose GLUC-PAP
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30080
Roche
cobas b 123 <3> POC system; cobas b 123 <4> POC system
Advice regarding a software upgrade. HPRA Ref: V29981
Siemens
syngo RT Therapist / syngo RT Oncologist (versions: 4.3.138, 4.3.SP1, 4.3.1_AR1, 4.3.1_MR2)
Advice regarding a software upgrade.HPRA REf: V29848
Siemens Healthcare Diagnostics
IMMULITE® 2000 / IMMULITE® 2000 Xpi Intact PTH kit
Advice regarding a device removal. HPRA Ref: V30036
Siemens Healthcare GmbH
Artis zee with SW versions VC21C, VD11 and Megalix Cat+ X-ray tubes
Advice regarding a software upgrade. HPRA Ref V29796
Siemens Healthcare GmbH
Artis Q systems with SW version VD11 and Gigalix X-ray tubes
Advice regarding a software upgrade. HPRA Ref: V29797
Siemens Healthcare GmbH
AXIOM Artis systems with SW version VB35E and Megalix X-ray tubes
Advice regarding a software upgrade. HPRA ref: V29799
Smith & Nephew
Reflection Dead Blow Mallet
Advice regarding a device removal. HPRA Ref: V29983
Stanmore Implants
Modular Tumour System
Advice regarding a device removal. HPRA Ref: V30042
Stryker
GAM Kirschner Wire, T2 K-Wire, T2 K-Wire Recon
Advice regarding a device removal. HPRA Ref: V29893
Teleflex
WECK Visistat 35W
Advice regarding a device removal. HPRA Ref: V29970
Teleflex Medical
ARROW® OnControl® Various Trays
Advice regarding a device removal. HPRA Ref: V29832
Trinity Biotech
Captia Syphilis IgG Kit
Advice regarding the use of the device. HPRA Ref: V29839
Wilson
Disposable Cleaing Brush
Advice regarding the use of the device. HPRA Ref: V29895
Xiros Ltd
Infinity-Lock and disposable instrument set
Advice regarding a device removal. HPRA Ref: V30018
Xiros Ltd
Infinity-Lock and disposable instrument set
Advice regarding a device removal. HPRA Ref: V30018
Zimmer Biomet
Optipac Bone Cement
Advice regarding a device removal. HPRA Ref: V30007
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Date Printed: 28/04/2024