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Summary of Field Safety Notices - March 2018
Notice type:
3rd Party Publications
Date:
05/04/2018
Further Information:
ACUTRONIC Medical Systems AG
fabian Therapy evolution
Advice regarding a device modification. HPRA Ref: V35195
ArjoJuntleight AB
Arjo Entroy GAB1000-x1
Advice regarding a device modification. HPRA Ref: V35135
Baxter
Ultrafilter U9000
Advice regarding changes/updates made to instructions for use. HPRA Ref: V35091
Beckman Coulter
iQ200 Series Urine Microscopy Analyzer
Advice regarding a software upgrade. HPRA Ref: V35172
Becton, Dickinson and Company
BD Vacutainer® Push Button Blood Collection Set
Advice regarding a device removal. HPRA Ref: V35208
Bentley Innomed
BeGraft Peripheral Stent Graft System
Advice regarding a device removal. HPRA Ref: V35196
BioFire Diagnostics, LLC
FilmArray® Blood Culture Identification (BCID) Panel
Advice regarding the use of the device. HPRA Ref: V35292
BÜHLMANN Laboratories
BÜHLMANN IBDoc
Advice regarding the use of the device. HPRA Ref: V35133
Caesare Medical Electronics Limited
T34 Ambulatory Syringe Pump
Advice regarding the use of the device. HPRA Ref: V35346
Cair LGL
3 Way Stopcock
Advice regarding a device removal. HPRA Ref: V35334
Cook Incorporated - Spencer
StoneBreaker® Pneumatic Lithotripter
Advice regarding a device removal. HPRA Ref: V35158
Cook Medical
Vacuum Pump
Advice regarding a device modification. HPRA Ref: V35086
Covidien LLC
LigaSure™ Exact Dissector, Nano-coated 20.6mm-21cm
Advice regarding a device removal. HPRA Ref: V35214
Cryolife
On-X Aortic & Mitral Heart Valves
Advice regarding the use of the device. HPRA Ref: V35128
DePuy Synthes
FLEX ARM INSTRUMENT
Advice regarding a device removal. HPRA Ref: V35360
Diamed
IH-1000
Advice regarding a software upgrade. HPRA Ref: V35142
Draeger Medical Systems, Inc.
"The Infinity® Acute Care System TM (lACS); all released software versions (from VG2.2 to VG6.0)
Standalone Infinity M540 patient monitor; all released versions (fromVG2.2 to VG6.0)"
Advice regarding the use of the device. HPRa Ref: V35003
Ethicon
Generator Gen11
Advice regarding a device modification. HPRA Ref: V35064
Euromi S.A.
EVA SP7
Advice regarding a device modification. HPRA Ref: V35276
Fannin LIP
W11050 Columbia Blood Agar
Advice regarding a device removal. HPRA Ref: V35342
Fannin LIP
Various Fannin Products
Advice regarding a device removal. HPRA Ref: V35093
Fresenius Kabi AG
Agilia Volumat Infusion Pump Lines
Advice regarding the use of the device. HPRA Ref: V34661
Getinge
APERLAN POKA YOKE (Agent A & Agent B)
Advice regarding a device removal. HPRA Ref: V35197
Halyard Health Inc
HALYARD CLOSED SUCTION KITS WITH FLEX CONNECTOR
Advice regarding the use of the device. HPRA Ref: V35096
HEINE Optotechnik GmbH & Co. KG
F.O. SP Laryngoscope handle
Advice regarding the use of the device. HPRA Ref: V35050
Herco Wassertechnik GmbH
HP xxx D/x/x with Hercotherm Ring
Advice regarding a device modification. HPRA Ref: V35042
Implant Direct Sybron Manufacturing LLC
InterActive® Healing Collar
Advice regarding a device removal. HPRA Ref: V35164
Kimal plc
Multi-lumen Altius Central Venous Catheter Kit
Advice regarding a device removal. HPRA Ref: V35339
Maquet Criticial Care AB
Servo-air, Servo-I, Servo-s, Servo-n, Servo-u
Advice regarding a device modification. HPRA Ref: V35049
Mast Group Ltd
Mast Uri System Software
Advice regarding a software upgrade. HPRA Ref: V35253
Medtronic
Versatex™ Monofilament Mesh 50 x 50 cm
Advice regarding the use of the device. HPRA Ref: V35059
Philips Medical Systems
Philips HeartStart MRx and FR3 Monitor/Defibrillator And HeartStart FR3 AED Used With Q-CPR Meter or CPR Sensor
Advice regarding changes/updates made to instructions for use. HPRA Ref: V34491
Philips Medical Systems
" Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT SP,
Brilliance Big Bore Oncology, Brilliance Big Bore Radiology, Brilliance 16, Brilliance 40, Brilliance
64, IQon, Brilliance 6, Brilliance 10"
Advice regarding a device modification. HPRA Ref: V35055
PTS Diagnostics
PTS Panels® CHOL+GLU test strips
Advice regarding a device removal. HPRA Ref: V35268
Radiometer
TCM5 Calibration Gas
Advice regarding the use of the device. HPRA Ref: V35145
Radiometer
Aqure System
Advice regarding the use of the device. HPRA Ref: V34994
Radiometer
TCM5 FLEX/BASIC used with ECG and EEG monitor
Advice regarding the use of the device. HPRA Ref: V33532
Richard Wolf GmbH
TEM Tube Set, single-use item, sterile
Advice regarding a device removal. HPRA Ref: V35373
Stryker
ETS. Hip endoprosthesis Head
Advice regarding a device removal. HPRA Ref: V35233
Sunrise Medical HCM B.V.
Quickie / Handicare Wheelchair
Advice regarding a device removal. HPRA Ref: V35102
ThermoFisher
ThermoScientificTM OxoidTM CT1412B CPO30 Cefpirome
Advice regarding a device removal. HPRA Ref: V35275
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Date Printed: 25/04/2024