SUMMARY OF FIELD SAFETY NOTIFICATIONS / JANUARY 2026

PRODUCT RECALL
Defibrilator/Monitor Efficia DFM100 / manufacturer Philips Goldway (Shenzhen) Industrial Inc, China
Ref. ANMDMR: 2/26

USER INFORMATION
Multi Unit Abutment / manufacturer Altatec GmbH, Germania
Ref. ANMDMR: 21/26

USER INFORMATION
Monitorul pentru pacienți 6500 / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 22/26

USER INFORMATION
INCIDIN™ ALCOHOL WIPE/ manufacturer Ecolab Deutschland GmbH, Germania
Ref. ANMDMR: 23/26

USER INFORMATION
Sistemele Allura Xper și Allura CV20 / manufacturer Philips Medical Systems Nederland BV, Țările de Jos
Ref. ANMDMR: 25/26

USER INFORMATION
Unităti de drenaj Sentinel Seal™, Altitude™, Aqua-Seal™, Thora-Seal™ / manufacturer Cardinal Health 200, LLC, SUA
Ref. ANMDMR: 27/26

PRODUCT RECALL
Swivel standing aid / manufacturer Burmeier GmbH & Co. KG, Germania
Ref. ANMDMR: 32/26

PRODUCT RECALL
Twist Drill and CCS Fully Threaded, / manufacturer Medartis AG, Eleveția
Ref. ANMDMR: 34/26

USER INFORMATION
High-Frequency Jet Ventilator monsoon 4 / manufacturer Thora Tech GmbH, Germania
Ref. ANMDMR: 35/26

USER INFORMATION
Triangle Tip Electrosurgical Knives / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 37/26

USER INFORMATION
BD neXus V700 Infusion Pump and BD neXus S700 Syringe Pump / manufacturer Medcaptain Medical Technology CO., LTD., China
Ref. ANMDMR: 39/26

USER INFORMATION
Olympus ShockPulse Lithotripsy System and Transducer / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 49/26

USER INFORMATION
QMAPP CPU Network connectivity / manufacturer Fysicon B.V., Țările de Jos
Ref. ANMDMR: 50/26

USER INFORMATION
IV I.V. Cannula 22G / manufacturer Disposafe Health and Life Care Limited., India
Ref. ANMDMR: 57/26

PRODUCT RECALL
MediHoney® Barrier and Derma non-sterile creams / manufacturer Derma Sciences, inc (in process in transitioning to Acell), Canada
Ref. ANMDMR: 60/26

USER INFORMATION
Sistemul intersomatic expandabil Catalyft™/ manufacturer Medtronic Sofamor Danek USA, Inc.,SUA
Ref. ANMDMR: 62/26

USER INFORMATION
Dispozitiv Tego™ / manufacturer ICU Medical Inc, SUA
Ref. ANMDMR: 63/26

USER INFORMATION
Inner sheaths of resectoscopes/ manufacturer Olympus Winter & Ibe GmbH, Germania
Ref. ANMDMR: 71/26

PRODUCT RECALL
Endo-Model SL, Endo-Model Knee System/ manufacturer Waldemar Link GmbH & Co.KG, Germania
Ref. ANMDMR: 72/26

USER INFORMATION
Monitoare pacient Philips IntelliVue / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 78/26

USER INFORMATION
Prismaflex set, Oxiris set / manufacturer Gambro Industries, Germania
Ref. ANMDMR: 85/26

PRODUCT RECALL
Olympus ViziShot 2 Flex/ manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 87/26

USER INFORMATION
ShockPulse Lithotripsy System / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 88/26

USER INFORMATION
A.T.S.® 5000TS and A.T.S.® 3200TS Tourniquet Systems / manufacturer Zimmer Surgical, Inc., SUA
Ref. ANMDMR: 92/26

USER INFORMATION
Cobas pro/pure non-monotonous Spline calibration / manufacturer Hitachi High-Technologies Corporation, Japonia
Ref. ANMDMR: 95/26

USER INFORMATION
Fibre Ringlight. / manufacturer LSO Medical, Franta
Ref. ANMDMR: 109/26

USER INFORMATION
Venous Bubble Sensor / manufacturer Heart-lung bypass System, Germania
Ref. ANMDMR: 115/26

USER INFORMATION
Forearm crutches Klassiker Kiddy Junior, Easy / manufacturer Ossenberg GmbH, Germania
Ref. ANMDMR: 116/26

USER INFORMATION
Dispozitiv de programare pentru clinician SynchroMed™ / manufacturer Medtronic, Inc., SUA
Ref. ANMDMR: 118/26

PRODUCT RECALL
Cystoscope Outer sheath / manufacturer Olympus Winter & Ibe GmbH, Germania
Ref. ANMDMR: 119/26

PRODUCT RECALL
Sfincterotome CleverCut și FlowCut/ manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 136/26

USER INFORMATION
Curated Variant Information (CVIs) / manufacturer Molecular Health GmbH, Germania
Ref. ANMDMR: 138/26

USER INFORMATION
TS-10 Automated Tube Sorter / manufacturer Sysmex Corporation Japan, Japonia
Ref. ANMDMR: 139/26

USER INFORMATION
Hamilton Medical ventilator Hamilton-C2 with neonatal option / manufacturer Hamilton Medical AG, Elveția
Ref. ANMDMR: 140/26

USER INFORMATION
Sistem Omni Legend / manufacturer GE Medical Systems LLC, SUA
Ref. ANMDMR: 145/26

PRODUCT RECALL
ThunderbeatTM Hand Instrument / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 145/146

USER INFORMATION
CS300 and CS100 Intra-Aortic Ballon Pumps / manufacturer Datascope Corp., SUA
Ref. ANMDMR: 147/26

USER INFORMATION
STA Liatest Free Protein / manufacturer Diagnostica Stago, Franța
Ref. ANMDMR: 152/26

USER INFORMATION
HLA-FluoGeneNX Match / manufacturer inno-train Diagnostik gmbH, Germania
Ref. ANMDMR: 156/26

USER INFORMATION
Piccolo Xpress Chemistry Analyzer / manufacturer Abaxis. Inc, Germania
Ref. ANMDMR: 161/26

USER INFORMATION
Breathing Circuits for Ventilators / manufacturer Fritz Stephan GmbH, Germania
Ref. ANMDMR: 172/26

USER INFORMATION
Sistemele Brilliance iCT, CT 6000, IQon, and Spectral CT / manufacturer Philips Medical Systems Nederland B.V., Țările de Jos
Ref. ANMDMR: 174/26

PRODUCT RECALL
Rebellion punch / manufacturer Morpheus AG, Germania
Ref. ANMDMR: 175/26

USER INFORMATION
Patient Information Center iX / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 176/26

USER INFORMATION
M-Medikation / manufacturer Meierhofer Medizintechnik, Germania
Ref. ANMDMR: 177/26

USER INFORMATION
Draeger Ventilator F120 / manufacturer Fritz Stephan GmbH, Germania
Ref. ANMDMR: 179/26

USER INFORMATION
Olympus High Flow Insufflation Unit / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 181/26

USER INFORMATION
Eva-Non Invasive ventilator / manufacturer JFR Medical Instruments GmbH, Germania
Ref. ANMDMR: 182/26

USER INFORMATION
EDAN Patient Monitoring and Fetal Monitoring Devices / manufacturer Edan Instruments, Inc., China
Ref. ANMDMR: 188/26

USER INFORMATION
MobileDiagnost wDR Mișcare neintenționată / manufacturer Philips Medical Systems DMC GmbH, Germania
Ref. ANMDMR: 210/26

USER INFORMATION
STA Liatest D-Di Plus / manufacturer Diagnostica Stago, Franța
Ref. ANMDMR: 222/26

PRODUCT RECALL
Dispozitivele Zimmer® Air Dermatome și Zimmer® Dermatome AN / manufacturer Zimmer Surgical, Inc., SUA
Ref. ANMDMR: 2004/25

PRODUCT RECALL
Sistem biopsie Brevera® / manufacturer Hologic, Inc., SUA
Ref. ANMDMR: 2018/25

PRODUCT RECALL
Extra-corporeal Circuit Tube / manufacturer Tianjin Plastics Research Institute Co., Ltd., China
Ref. ANMDMR: 7113/26

Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.