SUMMARY OF FIELD SAFETY NOTIFICATIONS / JUNE 2026
USER INFORMATION
Doppler cu Ultrasunete Maquet D900 furnizat împreună cu Cardiosave Hybrid Intra-Aortic Balloon
Pump (IABP) / manufacturer Datascope Corp., SUA
Ref. ANMDMR: 117/25
USER INFORMATION
Dispozitivele Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) / manufacturer Datascope Corporation, SUA
Ref. ANMDMR: 132/25
USER INFORMATION
Pompe de contrapulsație intraaortică CS100 și CS300 / manufacturer Datascope Corp., SUA
Ref. ANMDMR: 147/26
USER INFORMATION
Datascope Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) / manufacturer Datascope Corp., SUA
Ref. ANMDMR: 296/25
USER INFORMATION/
Test de diagnostic Biofire Ji Panel / manufacturer BioFire Diagnostics, LLC, SUA
Ref. ANMDMR: 861/26
PRODUCT RECALL
Solutie salină Deltamedica / manufacturer Deltamedica GmbH, Germania
Ref. ANMDMR: 1185/26
USER INFORMATION
Connector pentru Monitoare fetale din gama Philips Avalon / manufacturer Philips Medizin Systeme Böblingen GmbH, Germania
Ref. ANMDMR: 1187/26
PRODUCT RECALL
Sisteme Relay Pro de grefă stent toracic, N4 / manufacturer Bolton Medical, Inc. (subsidiary of Terumo Medical, SUA
Ref. ANMDMR: 1201/26
USER INFORMATION
Dispozitivul IntelliCuff / manufacturer Hamilton Medical AG, Elveția
Ref. ANMDMR: 1208/26
PRODUCT RECALL
Canulă orofaringiană Guedel / manufacturer IntersurgicaL Ltd., Marea Britanie
Ref. ANMDMR: 1215/26
USER INFORMATION
Set de transfer ChemoLock™ / manufacturer ICU Medical Inc, SUA
Ref. ANMDMR: 1217/26
USER INFORMATION
Medumat Standard / manufacturer Weinmann Emergency Medical Technology GmbH, Germania
Ref. ANMDMR: 1218/26
USER INFORMATION
Port acces AirSeal® / manufacturer Conmed Corporation, SUA
Ref. ANMDMR: 1230/26
USER INFORMATION
Actualizarea Instrucțiunilor de utilizare pentru teaca deflectabilă FARADRIVETM / manufacturer Boston Scientific Corporation, SUA
Ref. ANMDMR: 1247/26
USER INFORMATION
Cip senzor / manufacturer EKF-diagnostic GmbH, Germania
Ref. ANMDMR: 1255/26
USER INFORMATION
ACS® Uni IM adapter / manufacturer implantcast GmbH, Germania
Ref. ANMDMR: 1260/26
USER INFORMATION
High Flow Insufflation Unit / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 1268/26
USER INFORMATION
Kit de analiză a mutațiilor genei EGFR din ADN-ul tumoral circulant / manufacturer EntroGen Inc., SUA
Ref. ANMDMR: 1274/26
USER INFORMATION
Sistemele de anestezie Carestation 620/650/650c și 750/750c – ventilația mecanică nu este eficientă în modul de ventilație cu control al volumului (VCV) / manufacturer Datex-Ohmeda, Inc., SUA
Ref. ANMDMR: 1275/26
USER INFORMATION
Sistem Integra® Omni-Tract® / manufacturer Integra Lifesciences Corporation, SUA
Ref. ANMDMR: 1279/26
USER INFORMATION
Stația centrală Xhibit utilizată cu un splitter DisplayPort
Pierderea semnalului audio și/sau video / manufacturer Spacelabs Healthcare Ltd, SUA
Ref. ANMDMR: 1284/26
PRODUCT RECALL
Aplicatori sferici pentru sistemul de radioterapie intraoperatorie Zeiss Intrabeam / manufacturer Carl Zeiss Meditec AG, Germania
Ref. ANMDMR: 1287/26
USER INFORMATION
Senzor Dexcom G7 / manufacturer Dexcom Inc., SUA
Ref. ANMDMR: 1306/26
USER INFORMATION
Diagrama de orientare a implantului (IOD) Stella 2.0 / manufacturer STAAR Surgical AG, Elvetia
Ref. ANMDMR: 1308/26
USER INFORMATION
The Angiographic C-arm Support / manufacturer Shimadzu Corporation, Japonia
Ref. ANMDMR: 1310/26
USER INFORMATION
Lifecodes LSA Class II Kit / manufacturer Immucor GTI Diagnostics, Inc., SUA
Ref. ANMDMR: 1320/26
USER INFORMATION
Aplicația Dexcom G6 / manufacturer Dexcom, Inc., SUA
Ref. ANMDMR: 1322/26
USER INFORMATION
Ventilator Leoni 4 / manufacturer Löwenstein Medical SE & Co. KG, Germania
Ref. ANMDMR: 1330/26
USER INFORMATION
Blephademodex/ manufacturer Laboratoires Théa, Franta
Ref. ANMDMR: 1332/26
USER INFORMATION
Cartuș de hemoperfuzie de unică folosință (seria HA) / manufacturer Jafron Biomedical Co., Ltd., China
Ref. ANMDMR: 1335/26
PRODUCT RECALL
MOA-2 Biopsy forceps, single use, sterile, 1,6 x 800 mm / manufacturer Fehling Instruments GmbH, Germania
Ref. ANMDMR: 1338/26
USER INFORMATION
Sistemele Philips Azurion și Allura / manufacturer Philips Medical Systems Nederland BV, Țările de Jos
Ref. ANMDMR: 1339/26
USER INFORMATION
Ventilatoarele Astral 100 și Astral 150 / manufacturer Resmed Pty Ltd, Australia
Ref. ANMDMR: 1343/26
PRODUCT RECALL
Canulă arterială dintr-o singură piesă alungită EOPA™ / manufacturer Medtronic, Inc, SUA
Ref. ANMDMR: 1347/26
USER INFORMATION
Aparate de ventilație LEONI plus / LEONI plus HFO / LEONI plus transport / manufacturer Löwenstein Medical SE & Co. KG, Germania
Ref. ANMDMR: 1351/26
PRODUCT RECALL
Seringă de control pentru angiografie cu adaptor rotative / manufacturer B. Braun Melsungen AG – Vascular Systems, Germania
Ref. ANMDMR: 1353/26
PRODUCT RECALL
Burghiul de 3.4 mm pentru SwiveLock® / manufacturer Arthrex Inc, SUA
Ref. ANMDMR: 1355/26
USER INFORMATION
Capac distal pentru duodenoscop / manufacturer Olympus Medical Systems Corporation, Japonia
Ref. ANMDMR: 1358/26
USER INFORMATION
Umidificator cu bule / manufacturer Hsiner, Taiwan
Ref. ANMDMR: 1359/26
USER INFORMATION
Canulă de irigare și aspirație Wal / manufacturer Human Med AG, Germania
Ref. ANMDMR: 1365/26
USER INFORMATION
Sistem de perfuzie Medima / manufacturer Medima Sp. z o.o., Polonia
Ref. ANMDMR: 1381/26
USER INFORMATION
Etichetă incorectă pentru suportul de perete al sistemului Cardiohelp-i / manufacturer Maquet Cardiopulmonary GmbH, Germania
Ref. ANMDMR: 1383/26
USER INFORMATION
Actualizare Instrucțiuni de utilizare pentru dispozitivul sleep safe harmony / manufacturer Fresenius Medical Care AG, Germania
Ref. ANMDMR: 39684/26
Please note: If you have questions regarding any of the aforementioned information, please contact the issuer of the field safety notification directly.