SUMMARY OF FIELD SAFETY NOTIFICATIONS / SEPTEMBER 2025
USER INFORMATION
Extension lines for single use / manufacturer Zibo Qiaosend Medical Articles Co., Ltd., China
Ref. ANMDMR: 674/25
USER INFORMATION
Sisteme da Vinci X și Xi / manufacturer Intuitive Surgical, Inc., SUA
Ref. ANMDMR: 691/25
USER INFORMATION
Stimulatoare cardiace ACCOLADE™/ manufacturer Cardiac Pacemaker Inc, SUA
Ref. ANMDMR: 941/25
PRODUCT RECALL
Spare parts for syringe pumps: Drive complete PSP, green claws, Spaceplus Perfusor Drive complete and Spaceplus Perfusor Drive Head with Claws & Tube / manufacturer B.Braun Melsungen AG, Germania
Ref. ANMDMR: 971/25
USER INFORMATION
Corpuls3 / manufacturer GS Elektromedizinische Geräte G. Stemple GmbH, Germania
Ref. ANMDMR: 991/25
PRODUCT RECALL
Reconstruction plates / manufacturer KLS Martin SE & Co. KG, Germania
Ref. ANMDMR: 1009/25
PRODUCT RECALL
REUSABLE TROCAR SYSTEM / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 1026/25
PRODUCT RECALL
Proteza vasculară Vascugraft Flow / manufacturer B. Braun Melsungen AG, Germania
Ref. ANMDMR: 1027/25
USER INFORMATION
Software Ashvins variant HEYEX 2 / HEYEX PACS / manufacturer MedicalCommunications GmbH, Germania
Ref. ANMDMR: 1048/25
USER INFORMATION
STA Liatest D-Di Plus / manufacturer Diagnostica Stago, Franța
Ref. ANMDMR: 1049/25
PRODUCT RECALL
Generatoare VNS Therapy™ SenTiva™ / SenTiva Duo™ / manufacturer LivaNova USA, Inc., SUA
Ref. ANMDMR: 1050/25
USER INFORMATION
Bronhoscop/ manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 1065/25
PRODUCT RECALL
Proteză genunchi LinkSymphoKnee / manufacturerWaldemar Link GmbH & Co.KG, Germania
Ref. ANMDMR: 1066/25
PRODUCT RECALL
AeroWalk Carbon Rollator / manufacturer Drive Medical GmbH & Co.KG, Germania
Ref. ANMDMR: 1068/25
PRODUCT RECALL
Stent periferic RENZAN™ / manufacturer MicroVention Europe SARL, Franța
Ref. ANMDMR: 1069/25
USER INFORMATION
Defibrilator extern Defigard HD-7/ manufacturer Schiller Medical, Franța
Ref. ANMDMR: 1094/25
PRODUCT RECALL
StimuLong Sono II Sets / manufacturer PAJUNK GmbH Medizintechnologie, Germania
Ref. ANMDMR: 1100/25
USER INFORMATION
FDR Visionary Suite / manufacturer SHIMADZU Corporation, Japonia
Ref. ANMDMR: 1135/25
USER INFORMATION
Blue sail EndoBule Endoscopic Stapler / manufacturer Changzhou Tongchuang Medical Instrument Technology Co., Ltd., China
Ref. ANMDMR: 1136/25
PRODUCT RECALL
Atlantis intraoral feature locating object for suprastructures (IO FLO-S)/ manufacturer Dentsply Implants Manufacturing GmbH, Germania
Ref. ANMDMR: 1137/25
PRODUCT RECALL
Neodent GM Helix Implant / manufacturer Neodent – JJGC Indústria e Comércio de Materiais Dentários S.A., Brazilia
Ref. ANMDMR: 1144/25
USER INFORMATION
Heater Unit HU 35 / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 1151/25
USER INFORMATION
Cateter de ablație TactiFlex™ Sensor Enabled™ / manufacturer Abbott, SUA
Ref. ANMDMR: 1160/25
USER INFORMATION
Sistemele Philips Allura Xper, Allura CV20 și Allura Centron/ manufacturer Philips Medical Systems Nederland BV., Țările de Jos
Ref. ANMDMR: 1161/25
USER INFORMATION
Sistem Philips Allura/ manufacturer Philips Medical Systems Nederland BV, Țările de Jos
Ref. ANMDMR: 1162/25
USER INFORMATION
Sistem anestezie Atlan / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 1181/25
USER INFORMATION
Vyntus products with SNIP/RHINO Option / manufacturer Jaeger Medical GmbH, Germania
Ref. ANMDMR: 1182/25
USER INFORMATION
Airvo 2 and myAirvo 2 / manufacturer Fisher & Paykel Healthcare Ltd, Noua Zeelandă
Ref. ANMDMR: 1196/25
PRODUCT RECALL
Hygenic Dental Dam / manufacturer The Hygenic Company, LLC, SUA
Ref. ANMDMR: 1201/25
PRODUCT RECALL
Sonde Vitrectomie ULTRAVIT® și HYPERVIT® / manufacturer Alcon Laboratories Inc., SUA
Ref. ANMDMR: 1213/25
USER INFORMATION
Automated Impella Controller for Impella Catheter / manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 1223/25
USER INFORMATION
Charging unit mounted W/T AC TS7500 / manufacturer Baxter Medical Systems GmbH + Co. KG, Germania
Ref. ANMDMR: 1224/25
USER INFORMATION
Uromed Silicone Balloon Catheter / manufacturer UROMED Kurt Drews KG, Germania
Ref. ANMDMR: 1235/25
PRODUCT RECALL
Implant dentar Neodent GM Helix Implant / manufacturer JJGC Indústria e Comércio de Materiais Dentários S.A., Brazilia
Ref. ANMDMR: 1236/25
USER INFORMATION
Dexcom G6 iOS App / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 1241/25
USER INFORMATION
Sharesource Claria application – Homechoice Claria automated peritoneal dialysis (APD) / manufacturer Baxter Healthcare SA, SUA
Ref. ANMDMR: 1243/25
PRODUCT RECALL
Luer bone rongeur 17cm curved / manufacturer Tekno-Medical Optik-Chirurgie GmbH; Germania
Ref. ANMDMR: 1246/25
USER INFORMATION
Alinity hq Analyzer / manufacturer Abbott Laboratories, SUA
Ref. ANMDMR: 1247/25
USER INFORMATION
HeartSine samaritan Pad-Pak and Pediatric-Pak / manufacturer Medical (Heartsine Technologies Ltd.), Marea Britanie
Ref. ANMDMR: 1248/25
USER INFORMATION
BRAF 600/601 StripAssay / manufacturer ViennaLab Diagnostics GmbH, Austria
Ref. ANMDMR: 1280/25
USER INFORMATION
Bronhofibroscopul OLYMPUS / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 1283/25
USER INFORMATION
ChemoLock™ Port / manufacturer ICU Medical Inc, SUA
Ref. ANMDMR: 1285/25
USER INFORMATION
MADSEN AccuScreen TEOAE/DPOAE/ABR Probe / manufacturer Path Medical GmbH, Germania
Ref. ANMDMR: 1286/25
USER INFORMATION
Stație Centrală Carescape™ / manufacturer GE Medical Systems Information Technologies, Inc., SUA
Ref. ANMDMR: 1288/25
PRODUCT RECALL
Pompa insulina Tandem Diabetes Care™ t:slim X2 / manufacturer Tandem Diabetes Care, Inc., SUA
Ref. ANMDMR: 1294/25
USER INFORMATION
Eschweiler combiline / Eschweiler modularPro with Glucose and/or Lactat Sensors / manufacturer Eschweiler GmbH & Co. KG, Germania
Ref. ANMDMR: 1295/25
USER INFORMATION
Biosteon Screw / manufacturer Biocomposites LTD, Marea Britanie
Ref. ANMDMR: 1296/25
PRODUCT RECALL
Suportul pentru nas original furnizat cu lupa Dragonfly™ sau Phantom™ / manufacturer Metrex Research LLC dba Orascoptic, SUA
Ref. ANMDMR: 1312/25
USER INFORMATION
MassCheck® Dried Blood Spot Control Bi-Level I+II / manufacturer Chromsystems Instruments & Chemicals GmbH, Germania
Ref. ANMDMR: 1325/25
PRODUCT RECALL
Rezervă inteligentă cu vârf curbat și diametru mic Signia™ Medtronic / manufacturer Covidien llc, SUA
Ref. ANMDMR: 1326/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.