SUMMARY OF FIELD SAFETY NOTIFICATIONS / JANUARY 2025
USER INFORMATION
Compatibilitate seringa heparină / manufacturer Fresenius Medical Care AG, Germania
Ref. ANMDMR: 2226/25
USER INFORMATION
CGM CLINICAL Medication / manufacturer CompuGroup Medical Software GmbH
Ref. ANMDMR: 6092/25
USER INFORMATION
Intermediate ceiling construction / manufacturer KLS Martin SE & Co. KG, Germania
Ref. ANMDMR: 6094/25
USER INFORMATION
Figulla Flex II ASD / manufacturer Occlutech GmbH, Germania
Ref. ANMDMR: 6105/25
USER INFORMATION
HemosIL Liquid Anti-Xa/ manufacturer Instrumentation Laboratory Co., SUA
Ref. ANMDMR: 6296/25
USER INFORMATION
mint Lesion™ / manufacturer Mint Medical GmbH, Germania
Ref. ANMDMR: 6802
USER INFORMATION
VNS Therapy™ Generators – Model 1000 SenTiva™ si 1000-D SenTiva Duo™ / manufacturer LivaNova USA, Inc., USA
Ref. ANMDMR: 7074/25
USER INFORMATION
Infinity® CentralStation / manufacturer Draeger Medical System, Inc., SUA
Ref. ANMDMR: 8151/25
USER INFORMATION
DeepUnity Viewer 2.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 8156/25
USER INFORMATION
iGFBP-1 Rapid Test Cassette (Vaginal Secretion) / manufacturer Hangzhou Alltest Biotech Co.,Ltd., China
Ref. ANMDMR: 8158/25
USER INFORMATION
Videoprocesorul PENTAX MEDICAL EPK-i8020c și videoendoscoapele PENTAX Medical din seria i20c / manufacturer HOYA Corp., Japonia
Ref. ANMDMR: 8160/25
USER INFORMATION
Optipac® Vacuum mixing system / manufacturer Biomet France, Franta
Ref. ANMDMR: 8163/25
USER INFORMATION
Heparin syringe compatibility with 4008H, 4008B, 4008S / manufacturer Fresenius Medical Care AG, Germania
Ref. ANMDMR: 9306/25
USER INFORMATION
Raised toilet seats: SmartFix and TSE 2.0 / manufacturer DIETZ GmbH, Germania
Ref. ANMDMR: 9308/25
USER INFORMATION
Surgical soft-tissue manipulation forceps / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 9311/25
USER INFORMATION
Device sterilization/disinfection container / manufacturer Aesculap AG, Germania
Ref. ANMDMR: 9315/25
USER INFORMATION
Electrosurgical Electrode / manufacturer Dongguan QueenMed Equipment Mfg Co Ltd,China
Ref. ANMDMR: 9319/25
PRODUCT RECALL
Potential contamination with process-related foreign particles / manufacturer HMT Medizintechnik GmbH, Germania
Ref. ANMDMR: 9322/25
USER INFORMATION
3M™ Transbond™ Self-Etching Primer / manufacturer 3M Unitek Corporation, SUA
Ref. ANMDMR: 9330/25
USER INFORMATION
Toric Intraocular Lenses / manufacturer Carl Zeiss Meditec AG, Germania
Ref. ANMDMR: 9336/25
USER INFORMATION
Actualizare software pentru ventilatorul de terapie intensivă elisa 300/500/600/800/800VIT / manufacturer Löwenstein Medical Innovation GmbH & Co. KG, Germania
Ref. ANMDMR:11055/25
USER INFORMATION
BeneFusion nSP (Configured PCA ) / manufacturer Shenzhen Mindray Scientific Co., Ltd., China
Ref. ANMDMR: 11240/25
PRODUCT RECALL
Lumenis Pulse 120H Holmium Laser Systems / manufacturer Lumenis Ltd., Israel
Ref. ANMDMR: 12077/25
PRODUCT RECALL
Dispozitivul de embolizare Pipeline™ Vantage cu Shield Technology™ / manufacturer Micro Therapeutics, Inc, SUA
Ref. ANMDMR: 12153/25
USER INFORMATION
Corrosion of the Ice Bracket inside the water tank / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 12931/25
USER INFORMATION
Xhibit Telemetry Receiver / manufacturer Spacelabs Healthcare Inc, USA
Ref. ANMDMR: 12935/25
USER INFORMATION
Sedaconda Syringe / manufacturer Sedana Medical Ltd, Irlanda
Ref. ANMDMR: 12948/25
PRODUCT RECALL
Catheters- lifecath PICC pur / manufacturer Vygon GmbH & Co. KG, Germania
Ref. ANMDMR: 12975/25
USER INFORMATION
Sistemele Philips Allura and Azurion / manufacturer Philips Medical Systems Nederland BV, Olanda
Ref. ANMDMR: 12978/25
USER INFORMATION
Sistemele Philips Allura şi Azurion / manufacturer Philips Medical Systems Nederland BV, Olanda
Ref. ANMDMR: 13001/25
USER INFORMATION
Sistemele cu pompe de insulină MiniMed™ Paradigm™, MiniMed™ Seria 600 și MiniMed™ din seria 700 / manufacturer Medtronic Minimed, SUA
Ref. ANMDMR: 13061/25
PRODUCT RECALL
Pulsar-35 Self -expanding Nitrinol Stent System / manufacturer Biotronik AG, Elveția
Ref. ANMDMR: 13063/25
USER INFORMATION
CRP IP Reagent / manufacturer VitalScientific, Franta
Ref. ANMDMR: 13239/25
USER INFORMATION
Bone screw / manufacturer Medartis AG, Elveția
Ref. ANMDMR: 13261/25
USER INFORMATION
DeepUnity Viewer 2.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 13275/25
USER INFORMATION
Medima Infusion Pump / manufacturer Medima Sp. z o. o., Polonia
Ref. ANMDMR: 13278/25
PRODUCT RECALL
Thermo Scientific™ Yersinia Selective Agar / manufacturer Oxoid Deutschland GmbH, Germania
Ref. ANMDMR: 13280/25
USER INFORMATION
Defecțiuni ale cablurilor de înclinare la pensa Tenaculum și instrumentul Small GraptorTM de la da Vinci X și Xi / manufacturer Intuitive Surgical, Inc., USA
Ref. ANMDMR: 13284/25
USER INFORMATION
Defecțiuni ale cablului de prehensor pe instrumentele reutilizabile da Vinci X și Xi cu fălci / manufacturer Intuitive Surgical, Inc., SUA
Ref. ANMDMR: 13287/25
USER INFORMATION
Implantable Ventricular Circulatory Assist System / manufacturer HeartWare Inc., SUA
Ref. ANMDMR: 13357/25
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 13381/25
USER INFORMATION
ORBIS Medication 3.x / manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 13382/25
USER INFORMATION
Cartuș BD PCR / manufacturer Becton, Dickinson and Company, SUA
Ref. ANMDMR: 307.757/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.