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Summary of Field Safety Notices- June 2023
Notice type:
3rd Party Publications
Date:
05/07/2023
Further Information:
Abbott Diagnostic Technologies AS
Alere Afinion 2, Afinion 2
Advice regarding a software upgrade. HPRA Ref: V55321
Aescaulap AG
MINOP Trocar
Advice regarding a device removal. HPRA Ref: CRN00DP3T
Allen Medical Systems, Inc.
Allen Advance Chest Support w/pad
Advice regarding a device removal. HPRA Ref: CRN00DLSP
Altomed Limited
Damato Ruthenium Plaque Template
Advice regarding a device removal. HPRA Ref: CRN00DLT8
Anhui Anyu Latex Products Co., Ltd
Sterile Latex Surgical Gloves, MEDISTOCK brand
Advice regarding a device removal. HPRA Ref: CRN00DLZV
Balanced Body, Inc.
Studio Reformer
Advice regarding the use of the device. HPRA Ref: V53719
Beckman Coulter Diagnostics Limited
DxA 5000 Automation System
Advice regarding the use of the device. HPRA Ref: CRN00DMDG
Beckman Coulter Diagnostics Limited
DxI 9000 Access Immunoassay Analyzer
Advice regarding the use of the device. HPRA Ref: V55298
Biomérieux
EBV R-GENE an BK Virus R-GENE
Advice regarding the use of the device. HPRA Ref: V55328
Datascope Corp. Getinge
Cardiosave Intra-Aortic Balloon Pumps
Advice regarding a device modification. HPRA Ref: CRN00DM2V
Fannin Ltd
Columbia Blood Agar
Advice regarding the use of the device. HPRA Ref: CRN00DMKY
Flexicare Group Ltd
BriteBlade Pro
Advice regarding a device removal. HPRA Ref: CRN00DM1C
Full Vision Inc
Trackmaster Treadmills
Advice regarding the use of the device. HPRA Ref: CRN00DP2J
GE Healthcare
Flexiview 8800, OEC 9800, OEC 9900 and OEC Elite
Advice regarding a device modification. HPRA Ref: CRN00DMLM
GE Healthcare
Certain Vivid S60 / Vivid S70 / Vivid S60N / Vivid S70N Ultrasound Systems
Advice regarding a software upgrade. HPRA Ref: CRN00DP0Q
Getinge
Heater Cooler Unit HCU 40
Advice regarding the use of the device. HPRA Ref: V54319
Hamilton Bonaduz AG
CO-RE Tips; CO-RE II Tips
Advice regarding a device removal. HPRA Ref: CRN00DMD4
iMDsoft Ltd.
MetaVision
Advice regarding a software upgrade. HPRA Ref: CRN00DNTW
INTEGRA LifeSciences Mansfield
Codman Cranial Access Kit without drugs
Advice regarding a device removal. HPRA Ref: CRN00DNVV
Intuitive Surgical SAS
da Vinci Xi/X Tip-Up Fenestrated Grasper (470347-12)
Advice regarding a device removal. HPRA Ref: CRN00DM6M
Medtronic
Mahurkar Triple Lumen Catheter and Mahurkar High Pressure Triple Lumen Catheter
Advice regarding a device removal. HPRA Ref: CRN00DNTH
Medtronic Inc.
Vanta™ Implantable Neurostimulator (INS)
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DLT1
Medtronic MiniMed
MiniMed 780G Insulin Pump
Advice regarding a software upgrade. HPRA Ref: V46155
Megadyne Medical Products, Inc.
MEGADYNE™ MEGA SOFT™ and MEGA 2000 Reusable Patient Return Electrodes
Advice regarding the use of the device. HPRA Ref: CRN00DLPZ
Olympus Medical Systems Corporation
BF-Series Endoscopes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V55099
Olympus Winter & Ibe GmbH
HF-resection electrode
Advice regarding changes/updates made to instructions for use. HPRA Ref: CRN00DM9S
Organ Recovery Systems, Inc.
LifePort Kidney Transporter V1.1
Advice regarding a device modification. HPRA Ref: CRN00DNX9
Philips Goldway (Shenzhen) Industrial Inc.
Philips HeartStart Intrepid Monitor/Defibrillator
Advice regarding a device modification. HPRA Ref: CRN00DM38
Philips Medical Systems Nederland BV
Philips Azurion, Philips Allura Xper
Advice regarding a device modification. HPRA Ref: CRN00DM2L
Philips Medical Systems Nederland BV
Philips Allura Xper and Azurion Systems
Advice regarding the use of the device. HPRA Ref: CRN00DP6F
Phillips Medical Systems
IntelliVue MX40 Patient Monitor
Advice regarding the use of the device. HPRA Ref: CRN00DLSX
QuidelOrtho
Triage Cardiac Panel
Advice regarding a device removal. HPRA Ref: CRN00DLXH
Randox Laboratories Ltd
Urea Enzymatic Kinetic Assay
Advice regarding the use of the device. HPRA Ref: CRN00DLWZ
Spacelabs Healthcare
Spacelabs Ultraview SL (UVSL) Command Module, Model 91496
Advice regarding the use of the device. HPRA Ref: V55306
Xiros Ltd
CC-Hook
Advice regarding the use of the device. HPRA Ref: V55275
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Date Printed: 29/04/2024