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Summary of Field Safety Notices - July 2019
Notice type:
3rd Party Publications
Date:
01/08/2019
Further Information:
Ad-Tech Medical Instrument Corporation
Ad-Tech Bolt - Directions for User
Ad-Tech Bolt - FSN
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40591
Air Liquide Medical Systems
Monnal T40, T50, T60, T75 Ventilators, Monnal EVA EXPI. Autoclavable Valve
Advice regarding the use of the device. HPRA Ref: V40939
ALCIS
Dental arch ALBAFLEX 2099-AS
Advice regarding a device removal. HPRA Ref: V39456
Andramed GmbH
ANDRASTENT XXL
Advice regarding a device removal. HPRA Ref: V39897
B. Braun Medical Ltd
INFUSOMAT SPACE LINE, TRANSFUSION
Advice regarding a device removal. HPRA Ref: V40861
BD Switzerland Sàrl
BD Max Reagents
Advice regarding the use of the device. HPRA Ref: V40712
Becton Dickinson Consumer Healthcare
BD Microtainer® Tubes
Advice regarding a device removal. HPRA Ref: V40270
Clinical Innovations
KIWI Complete Vacuum Delivery System (VAC-6000MTE)
Advice regarding a device removal. HPRA Ref: V40756
Coloplast
Simpla Profile
Advice regarding a device removal. HPRA Ref: V40726
Criutical Diagnostics
Presage ST2 Assay
Advice regarding a device modification. HPRA Ref: V40385
Datascope Corp. Getinge
Cardiosave, CS100,CS300 Intra-Aortic Balloon Pumps
Advice regarding a software upgrade. HPRA Ref: V40461
Dexcom
Dexcom G4 Platinum, G5 Mobile CGM system
Advice regarding the use of the device. HPRA Ref: V40592
Edwards Lifesciences
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40779
Elekta
Monaco® RTP System
Advice regarding a software upgrade. HPRA Ref: V40642
Evolutis
Christmas tree teeth rasps, size 7 to 20 female
Advice regarding a device removal. HPRA Ref: V40590
Fast Track Diagnostics
FTD Lyophilized products
Advice regarding a device modification. HPRA Ref: V40325
GE Medical System (China) Co. Ltd
Achilles EXP II
Advice regarding a device modification. HPRA Ref: V39915
GE Medical Systems Information Technologies, Inc.
MAC VU360 Resting ECG Analysis System
Advice regarding a software upgrade. HPRA Ref: V40916
Grace Medical Inc.
Cartilage Microtome System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40714
Hain Lifescience GmbH
GXT NA Extraction Kit VER 1.0 ; / 12.08.02
Advice regarding the use of the device. HPRA Ref: V39341
Herdegen
ADVANCE model crutches
Advice regarding a device removal. HPRA Ref: V40630
Intersurgical Ltd
Various respiratory devices with swivel elbows
Advice regarding a device removal. HPRA Ref: V40898
Intuitive
da Vinci Xi® and da Vinci X® Systems
Advice regarding a device modification. HPRA Ref: V40901
Johnson and Johnson GmbH
Neutrogena Light Therapy Acne Mask and Refill Activator - Consumer FSN
Neutrogena Light Therapy Acne Mask and Refill Activator - Retail Pharmacy FSN
Advice regarding a device removal. HPRA Ref: V40485
MERCIAN
HA5806-21 Mallet with Black Handle 21.5cm 40mm Diameter 900g
Advice regarding a device modification. HPRA Ref: V40481
Ortho Clinical Diagnostics Inc
ORTHO VISION and VISION Max Analyzers
Advice regarding a software upgrade. HPRA Ref: V40855
Philips Healthcare
BrightView, BrightView X, BrightView XCT
Advice regarding a device modification. HPRA Ref: V40330
Philips Healthcare
Ingenuity CT, Ingenuity Core, Ingenuity Core 128, Brilliance 64, iCT, iCT SP, IQon, Ingenuity TF PET/CT, Vereos PET/CT
Advice regarding the use of the device. HPRA Ref: V40716
Philips Medical Systems
HeartStart MRx Defibrillator/Monitor
Advice regarding the use of the device. HPRA Ref: V40239
Randox Laboratories Ltd
Calibration Serum Level 3
Advice regarding the use of the device. HPRA Ref: V40660
Roche Diagnostics GmbH
Elecsys Anti-CCP
Advice regarding the use of the device. HPRA Ref: V40624
Roche Diagnostics GmbH
ONLINE TDM Vancomycin Gen.3 (VANC3)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40771
Sentinel CH. SpA
Lithium, Alinity c Lithium Reagent Kit. FSN 1
Lithium, Alinity c Lithium Reagent Kit. FSN 2
Advice regarding the use of the device. HPRA Ref: V40793
Siemens Healthcare Diagnostics Limited
ADVIA Centaur Folate
Advice regarding the use of the device. HPRA Ref: V40794
Siemens Healthcare Diagnostics Products Limited
IMMULITE/IMMULITE 1000 Progesterone, IMMULITE 2000/IMMULITE 2000 XPi Progesterone
Advice regarding the use of the device. HPRA Ref: V40643
Smith & Nephew Inc - Memphis
VLP MINI-MOD 2.0MM STRAIGHT PLATE 6 HOLE
Advice regarding a device removal. HPRA Ref: V39733
Smiths-Medical
GRIPPER® Needles and PORT-A-CATH® Trays Containing GRIPPER® Needles
Advice regarding a device removal. HPRA Ref: V40717
Stryker Medical
LIFEPAK 15 monitor/defibrillator
Advice regarding a device modification. HPRA Ref: V38682
Thoratec Corporation
HM3 Outflow Graft, HM3 LVAS Kit
Advice regarding a device removal. HPRA Ref: V39932
Uptake Medical
InterVapor System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40808
Zimmer Biomet
T7 Cannulated Driver AO and T7 Driver Solid AO
Advice regarding a device removal. HPRA Ref: V39749
Zimmer Biomet
Pulsavac® Plus Wound Debridement System and Pulsavac® Plus AC Wound Debridement System
Advice regarding a device removal. HPRA Ref: V40703
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Date Printed: 18/04/2024