SUMMARY OF FIELD SAFETY NOTIFICATIONS / OCTOBER 2025
PRODUCT RECALL
Mediloop / manufacturer Neuromedex GmbH, Germania
Ref. ANMDMR: 1323/25
PRODUCT RECALL
Rezervă inteligentă cu vârf curbat și diametru mic Signia™ Covidien/ manufacturer Covidien LLC, SUA
Ref. ANMDMR: 1326/25
USER INFORMATION
Orbis Medication 3.x/manufacturer DH Healthcare GmbH, Germania
Ref. ANMDMR: 1327/25
USER INFORMATION
CRP FS / manufacturer DiaSys Diagnostic Systems GmbH, Germania
Ref. ANMDMR: 1340/25
USER INFORMATION
CT 5300 și Incisive CT cu versiunea software V5.1/manufacturer Philips Healthcare (Suzhou) Co., Ltd, China
Ref. ANMDMR: 1341/25
USER INFORMATION
Standard dressing forceps/ manufacturer Tekno-Medical Optik Chirurgie GmbH, Germania
Ref. ANMDMR: 1353/25
PRODUCT RECALL
ZipTight™ Fixation System for AC Joint Repair / manufacturer Biomet Sports Medicine, SUA
Ref. ANMDMR: 1357/25
USER INFORMATION
Defibrilator extern Reanibex 300/500 / manufacturer Osatu S. Coop., Spania
Ref. ANMDMR: 1362/25
USER INFORMATION
Salem Sump™ Stomach Tubes with Anti-Reflux Valve / manufacturer Cardinal Health 200 LLC, SUA
Ref. ANMDMR: 1364/25
USER INFORMATION
Kapillardrain / manufacturer Primed Halberstadt Medizintechnik GmbH, Germania
Ref. ANMDMR: 1368/25
USER INFORMATION
AW Server / manufacturer GE Medical Systems SCS, Franta
Ref. ANMDMR: 1372/25
USER INFORMATION
Ello / manufacturer VOSS healthcare GmbH, Germania
Ref. ANMDMR: 1386/25
USER INFORMATION
Sekumatic NDT/ manufacturer Ecolab Deutschland GmbH, Germania
Ref. ANMDMR: 1388/25
PRODUCT RECALL
Vitus-Fi Distal Fibula Nail / manufacturer Dieter Marquardt Medizintechnik GmbH, Germania
Ref. ANMDMR: 1389/25
USER INFORMATION
Pompe seringi BD Alaris™/ manufacturer BD Switzerland Sàrl, Elveția
Ref. ANMDMR: 1390/25
USER INFORMATION
Ventilator BiPAP A40 Pro / manufacturer Philips Respironics, Inc., SUA
Ref. ANMDMR: 1402/25
USER INFORMATION
Vaporizator V90 / manufacturer Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China
Ref. ANMDMR: 1406/25
USER INFORMATION
Avanos Introducer Kit for Gastrostomy feeding Tubes/ manufacturer Avanos Medical Inc, SUA
Ref. ANMDMR: 1412/25
USER INFORMATION
Alinity hq Analyzer / manufacturer Abbott Laboratories, SUA
Ref. ANMDMR: 1413/25
PRODUCT RECALL
Single Use Electrosurgical Snare SD-400 / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 1417/25
USER INFORMATION
Olympus duodenoscope / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 1420/25
USER INFORMATION
Catalyst+ HD, Catalyst HD / manufacturer C-RAD Positioning AB, Suedia
Ref. ANMDMR: 1422/25
USER INFORMATION
Swing-Band® / manufacturer THT Bio-Science, Franta
Ref. ANMDMR: 1428/25
USER INFORMATION
Azurion 7M20 cu stativ FlexArm / manufacturer Philips Medical Systems Nederland BV, Olanda
Ref. ANMDMR: 1429/25
USER INFORMATION
Controlerele de sistem HeartMate II® și HeartMate 3™ utilizate cu HeartMate 3™ LVAS și HeartMate II® LVAS / manufacturer Abbott Medical, SUA
Ref. ANMDMR: 1430/25
USER INFORMATION
Pompă de sânge CentriMagTM /manufacturer Abbott Medical, SUA
Ref. ANMDMR: 1431/25
USER INFORMATION
ShockPulse Lithotripsy Transducer / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 1432/25
USER INFORMATION
sisteme de medicină nucleară/ manufacturer GE medical Systems Israel, Functional Imaging, Israel
Ref. ANMDMR: 1433/25
PRODUCT RECALL
CitraLock Syringe 4%/manufacturer Sterisets Manufacturing S.A, Portugalia
Ref. ANMDMR: 1434/25
USER INFORMATION
Ultramat S / manufacturer SDI Limited, Australia
Ref. ANMDMR: 1437/25
USER INFORMATION
Easy Pulse / manufacturer Schiller AG, Elvetia
Ref. ANMDMR: 1444/25
USER INFORMATION
Bio-Rad GenieTM Fast HIV 1/2 / manufacturer Bio-Rad, Franta
Ref. ANMDMR: 1445/25
USER INFORMATION
Giraffe OmniBed și Giraffe OmniBed Carestation/ manufacturer Datex-Ohmeda Inc, SUA
Ref. ANMDMR: 1453/25
USER INFORMATION
Analizorul digital automat de morfologie celulară DI-60 / manufacturer CellaVision AB, Suedia
Ref. ANMDMR: 1454/25
USER INFORMATION
Autocal, Cholesterol Liquicolor / manufacturer Human Gesellschaft für Biochemica und Diagnostica mbH, Germania
Ref. ANMDMR: 1456/25
USER INFORMATION
Monitor de pacient 6500/ manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 1457/25
USER INFORMATION
Liaison® C. difficile Toxins A&B / manufacturer Diasorin Inc, SUA
Ref. ANMDMR: 1460/25
USER INFORMATION
Digital Radiography System and Ceiling type X-RAY tube support / manufacturer Shimadzu Corporation, Japonia
Ref. ANMDMR: 1470/25
USER INFORMATION
Samsung Digital Diagnostic Mobile X-ray System GM85/ manufacturer Samsung Electronics Co., Limited, Coreea
Ref. ANMDMR: 1471/25
USER INFORMATION
PakPlus® / manufacturer Immucor GTI Diagnostics (A Werfen Company), SUA
Ref. ANMDMR: 1472/25
USER INFORMATION
Medap Twista SP, Medap Bora UP, Medap Venta SP și Atmos Varioair 3 / manufacturer ATMOS MedizinTechnik GmbH & Co. KG, Germania
Ref. ANMDMR: 1479/25
USER INFORMATION
Cărucior FlexTrak reglabil pe înălțime / manufacturer Philips Medical Systems Nederland B.V, Tarile de Jos
Ref. ANMDMR: 1482/25
USER INFORMATION
Sistem de compresie secvențială Kendall SCD™ 700, / manufacturer Cardinal Health 200, LLC, SUA
Ref. ANMDMR: 1490/25
USER INFORMATION
Acul hipodermic KD-FINE® SAFETY / manufacturer KD Medical GmbH Hospital Products, Germania
Ref. ANMDMR: 1491/25
USER INFORMATION
ShockPulse Lithotripsy Transducer / manufacturer Gyrus ACMI, Inc. (Olympus Surgical Technologies America), SUA
Ref. ANMDMR: 1492/25
USER INFORMATION
Ultramat S / manufacturer SDI Limited, Australia
Ref. ANMDMR: 1493/25
USER INFORMATION
Analizoarele de imunologie UniCel DxI 600 și 800 / manufacturer Beckman Coulter, Inc., SUA
Ref. ANMDMR: 1495/25
USER INFORMATION
Automated Impella Controller (AIC) – AIC Purge Retainer Fixation Correction / manufacturer Abiomed Inc., SUA
Ref. ANMDMR: 1496/25
USER INFORMATION
Setpack/ Toptex Laparotomy Swabs / manufacturer Lohmann & Rauscher International, Germania
Ref. ANMDMR: 1499/25
PRODUCT RECALL
Zen-O lite™ Portable Oxygen Concentrator / manufacturer Gas Control Equipment Ltd, Marea Britanie
Ref. ANMDMR: 1503/25
USER INFORMATION
MAS® Omni•CARDIO™ Liquid Assayed Integrated Cardiac Control / manufacturer Microgenics Corporation, as part of Thermo Fisher Scientific, SUA
Ref. ANMDMR: 1516/25
USER INFORMATION
CareLink™ Clinic / manufacturer Medtronic MiniMed, SUA
Ref. ANMDMR: 1517/25
USER INFORMATION
MAC VU360 Acquisition Trunk Cable and Module Holder / manufacturer GE Medical Systems Information Technologies, Inc., SUA
Ref. ANMDMR: 1518/25
USER INFORMATION
ELECTROLYTE ANALYZER W/O STARTERKIT 9180 / manufacturer Roche Diagnostics GmbH, Germania
Ref. ANMDMR: 1519/25
USER INFORMATION
Intranasal Mucosal Atomization Device / manufacturer Pulmodyne Inc., SUA
Ref. ANMDMR: 1523/25
USER INFORMATION
Evis Exera III Colonovideoscope / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 1529/25
USER INFORMATION
Dräger Catheter Mounts ErgoStar CM 40, ErgoStar CM 45, ErgoStar CM 55, ErgoStar CM 60 / manufacturer Drägerwerk AG & Co. KGaA, Germania
Ref. ANMDMR: 1530/25
USER INFORMATION
Sistem imagistică cu rezonanţă magnetică (IRM) / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 1536/25
USER INFORMATION
Sistem imagistică cu rezonanţă magnetică (IRM) / manufacturer Siemens Healthcare GmbH, Germania
Ref. ANMDMR: 1537/25
USER INFORMATION
SLsolution™ / manufacturer Copan Italia Spa, Italia
Ref. ANMDMR: 1546/25
USER INFORMATION
Sistemele Philips Allura Xper / manufacturer Philips Medical Systems Nederland BV, Țările de Jos
Ref. ANMDMR: 1547/25
USER INFORMATION
Ceiling suspension of Philips Diagnostic X-Ray (DXR) systems/ manufacturer Philips Medical Systems DMC GmbH, Germania
Ref. ANMDMR: 1550/25
USER INFORMATION
Biosen Linearity Test Kit / manufacturer EKF-diagnostic GmbH, Germania
Ref. ANMDMR: 1551/25
USER INFORMATION
Celox PPH Uterine Haemostatic Tamponade / manufacturer Medtrade Products Ltd, Marea Britanie
Ref. ANMDMR: 1553/25
USER INFORMATION
Bicarbonat / manufacturer Beckman Coulter Ireland Inc., Irlanda
Ref. ANMDMR: 1556/25
USER INFORMATION
BRAF 600/601 StripAssay /manufacturer ViennaLab Diagnostics GmbH, Austria
Ref. ANMDMR: 71048/25
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.